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P a g e 1 | 11
CURRICULUM VITAE
Mrs Louise Kriel
APPLICATION DETAILS:
Position Wanted:
Position Related to Quality Systems / Assurance -
Validation Engineer
Years’ Experience: 9
Career Level: Senior
Current Monthly Salary: R45000
Expected Monthly Salary: R45000 - R50000
Preferred Areas: Cape Town
Transport: Own
Notice Period: 1 Months' Notice
SUMMARY OF EXPERIENCE RELEVANT TO POSITION APPLYING FOR:
- Quality Systems and Standards
- Good Manufacturing Practices
- Critical Control Parameters
- Project Management
- Compliance and Risk Management
- Change Control Process Owner
- Periodic Product Reviews
- NC / CAPA
- Training
- Capability Studies (Cpk)
- Consumer Complaints
- Product Release
- Audits
- Housekeeping
CAREER OBJECTIVES:
- I would like to work for a manager that is people orientated and a leader. Someone that can
mentor and help me develop myself when it is required for position or company.
- I am looking for an opportunity with an established and reputable organisation that would
offer me an opportunity to not only utilize my current knowledge, skills and experience, but
also afford me an opportunity to gain more experience to ensure and be awarded for
achievements and grow within the organisation.
PERSONAL ATTRIBUTES / ACHIEVEMENTS:
- My true strengths lie in my integrity, leadership, communication skills and ability to perform
well under pressure.
- I believe that my excellent analytical thinking skills, positive attitude, willingness to learn,
initiative and problem solving skills will be a benefit to your organisation.
- I understand the criticality of implementation of robust Quality Systems to ensure compliance
and attain Right First Time for processes and documentation which support traceability.
- Introduced and implemented Quality Systems (i.e. Personal Hygiene, Line set ups, Critical
Control Points for Line Operation, Products and Packaging, IPQC testing as well as line
P a g e 2 | 11
clearance and cleaning) in the SANPRO Department (Sanitary Napkins – Engineered
product) across all the lines to ensure compliance to Systems, Quality, cGMP and Good
Housekeeping)
- I have an excellent understanding on the Critical Control Processes Parameters during line
set up and manufacturing to ensure the adherence of products and processes to high quality
attributes and final product and system specifications and understand the criticality to
investigate and mitigate any risks to our consumers/customers.
- I have a very strong technical and analytical background for analysing of processes and data
also performance of Capabilities Studies (Cpk) for equipment and systems and final product
specifications utilizing Minitab.
- I can efficiently manage Projects through FPX methodology. Also use SMARTWAY
- I have an excellent understanding in managing Risks i.e. to products, consumer and business
and to implement Quality Systems or optimise current systems to avoid reoccurrences and to
eliminate possible audit findings by being pro-active.
- Can efficiently investigate Consumer Complaints, Deviation and Non-conformance utilizing
the CAPA process (Corrective and Preventative Actions).
- Change Control Owner for implementing changes efficiently for sustainability.
- Perform final product releases to the market for sale not only when they comply with the
product and packaging specification; but because of my knowledge of formulations and
packaging due to my expertise in Validations can comprehend out of trends, special events
and capabilities.
- Fully active in Audits (MCC, Internal Audits, ISO9001, Global Johnson & Johnson JJRC
Audits).
- My department did not receive any repeat or new finding in the last 2015 Global Audit
comparing it to the last 2011 Audit when the Validation Department was labelled as critical
because of all the gaps and non-compliance.
EDUCATION, TRAINING & COMPUTER LITERACY:
Secondary Qualification: Matric
School: Nico Malan
City/Town: Humansdorp
Year: 1998
Tertiary Qualification 1: B.Sc Biology Degree
Institution: Potchefstroom University
City/Town: Potchefstroom
Year: 1999
Computer Literacy:
- MS Word - Symphony
- Excel - Pastel
- Power Point - BAAN
- Publisher
- Minitab
- PRIDE
P a g e 3 | 11
EMPLOYMENT HISTORY:
Employer 1: Johnson and Johnson Pty Ltd
City/Town: East London
Date: May 2012 to date
Position: Quality Engineer - Validation
Monthly Salary: R42000.00
Duties:
- Directs Site Master Validation Plan activities in alignment with the regions Global Standards
and follow an End 2 End approach.
- Adhere to and implement where required strict Quality Systems when performing routine
tasks or projects and continuously improving in line with Best Practices, cGMP to ensure
compliance to expected standards.
- Managing and Reporting on the following Portfolios and Programs to local site and
management to ensure alignment and understanding of the expectation for each activity with
regards to timing and quality attributes to consistently and reliably be audit ready and in line
with the Regional Global Standards:
- Product Process Validation
- Cleaning Validation
- Packaging Validation
- Bulk Holding Time Studies
- Equipment Idle time Studies
- Periodic Facility and Utility Reviews
Quality Systems and Procedures
- Generate Quality Systems and Procedures for compliance and adherence to Global
standards, Best Practices and all aspects of cGMP.
- Implement and Train all on the Quality Systems implemented.
- Assess sites adherence to Quality Systems and Procedures trough audits and also “on the
job” monitoring when performing Process/Packaging and Cleaning Validations against
predetermined Critical Control Parameters.
- Document and Recommend effective solutions when required and optimisations relating to
the Quality Systems for products, procedures and systems in the validation reports.
Validation
- Validation of new and current products, packaging, utilities and facilities in line with
Acceptable Quality Limits and regulations, ensuring compliance as per quality SOP
- Adherence of products to strict, robust and realistic final product specifications
- Report on any variances and risk mitigation
- Assess Capabilities of equipment, processes and release specifications using Minitab.
P a g e 4 | 11
Compliance and Risk Management
- Understand the importance to communicate and be transparent with regards to consumer
information and comprehend the criticality to investigate, escalate and mitigate any risks to
our consumers/customers and business.
- Implementation of Best practices and ongoing Gap analysis against Global Standards to
ensure alignment and compliance
Risk and Safety Assessments and Root Cause studies
- Reviewing and mitigation of potential safety risks and hazards to consumer when performing
validation studies/Case Studies/Optimisations/ for Product produced, Packaging components
used, Cleaning and Sanitising Methods followed, Storage Temperatures monitored.
- FMEA Approach used.
- Perform Root cause analysis for deviation that occurs on validated product, procedures and
systems always taking into consideration the safety and health risks.
- Perform Corrective and Preventative action where deviations occurred through structured
systems.
Training
- Validation Training theoretical on a one-on-one with the relevant people and is practical
assessments when conducting studies. Training also entails criticality of GMP, Best Practices
and Aligning to Global Standards in line with the safety and quality commitment to our
consumers.
- To ensure an End 2 End process approach conduct training to ensure sustainability of
changes and new processes. As part of the Quality Assurance Team always involved with
the GMP training for site where required.
Generating of documentation (Protocols, Reports, SOPs, Risk Assessments, Quality System
Procedures)
- All documentation are handled confidential and in line with a document control process
- Always ensure all quality data is accurately documented and for evidence analysed and
trends and risks identified and reported on.
- Make sure all Master Validation plans are updated and effective
- Create protocols for Process, Cleaning and Packaging validation processes, evaluations and
case studies to be performed.
- Generate accurate validation reports reporting on all findings related to the validation
processes, evaluations and case studies and documenting any abnormalities or potential
risks that may occur.
- Create Standard Operating procedures for production to ensure adherence to Quality
Systems.
- Trending capabilities of procedures and systems through and report statistical data.
- Conclude products, procedures and the reports only if under suitable control and if it can
consistently meet the high quality and safety attributes expected.
- Recommend effective solutions relating to the products, procedures and systems in the
validation reports to conclude or optimize.

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P a g e 5 | 11
Change Control Process Owner:
- Actively part of the Change Control System on site and understand the criticality of
information and detail for managing and implementing changes efficiently for sustainability.
Periodic Product Reviews:
- Critical to ensure processes and formulas are under suitable control and that there are no risk
to them taking into consideration but not limited to, batches produced, equipment used,
stability, changes, trending of assays and other final product specification
NC / CAPA:
- Investigation of Out Of Specifications, Out of Trends, Deviations for implementation of
Corrective and Preventative Actions.
Projects:
- Managing Projects and implementation through the FPX methodology. Also familiar with
SMARTWAY.
Capability Studies:
- This department is a Critical part in the Quality Assurance and Quality Control departments
and ensures that manufactured/packed products are of high quality and fit for our customers
use.
- This includes the assessing of Mixing and Line Capabilities of the equipment and product/
process specifications used utilizing Minitab and Sig ΩSigma Methodology.
- This tool is to assess if a process, product, specification or limit is shifting and needs
investigation to eliminate possible risk.
Consumer Complaints:
- How to analyze categories of complaints and mitigate any risks. Satisfying the consumer in
such way to protect them, the company and the integrity of the product in the market.
Product Release:
- Release Products when they comply with the final product specifications and investigate out
of trends taking the validation results for the product into consideration to ensure it remains
within its design space and is robust.
Audits:
- Exposed and actively involved in audits. Preparing and implementation of Corrective actions
for closure. (MCC, ISO, MRASS, Johnsons Global JJRC)
Started managing department after the 2011 Global Audit and the department were
labeled Critical. Received no repeat or new findings in the last Global Audit 2014
Troubleshooting
- Investigate and recommend effective solutions to issues arising within production
- Solving of problems through analytical processes
- Provide ongoing technical support to relevant departments
P a g e 6 | 11
Optimization, improvement of processes
- Advise and consult on recommended changes to production processes. (Pharmaceutical,
Cosmetics and Engineered products)
- Assist in solving capacity problems within the factory
- Advise and respond to needs within marketing relating to product re-engineering
- Obtain approval to any changes through the change control system in the manufacturing
process before implementation
- Implementation of identified and approved process changes within manufacturing by using
the CAPA and Symphony programs
Other
- Strict adherence to Standard Operating Procedures to ensure processes meets the quality
standards expected consistently.
- Updating and reviewing of all Product Specifications, Product Manufacturing, Packaging
documentation and Standard Operating Procedures and plans.
- Deliver quality and safety based assistance with to Optimisation of Manufacturing,
Processes, Cleaning processes of equipment and areas and Cost Saving Projects taking in
to consideration the design and what is realistic.
- Adherence to all legal requirements as agreed upon and reporting any adverse events to
ensure a safe environment for myself and other personnel.
- Initiate Change Control documents as required.
- Assist to optimise process procedures and related documentation.
- Recommend corrective/preventative actions (CAPA) relating to the validation executions and
reports.
- Investigate and recommend effective solutions to issues arising within production.
- Evaluating all CIPs, introducing newly tested CIP cleaning detergents and writing of the
standard operating procedures of each CIP programme
- Solving of problems through analytical evaluation of results.
- Provide ongoing technical support to relevant departments.
- Training of all operators and production personnel on new and current improved operational
and cleaning procedures.
- Performing Internal Audits
- Conclude all studies with documented evidence and implement best practices where
required.
Reason for leaving: Husband promoted – need to relocate to Cape Town
P a g e 7 | 11
Employer 2: Aspen Pharmacare Pty Ltd
City/Town: East London
Date: April 2008 to May 2012
Position: Validation Technologist
Monthly Salary: R20000
Duties:
Generating of documentation
- Generate validation protocols on DocCompliance for Quality Assurance
- Deliver assistance to optimize documentation in the manufacturing of trial batches
- Effective collection of samples to ensure in process testing
- Liaise with Laboratory re process testing
Validation Report
- Generate validation reports on DocCompliance, reporting on all findings related to the
validation process
- Recommend effective solutions relating the validation reports
Method of manufacture
- Generate standard method of manufacture documentation.
- Ensure that all relevant signatures have been obtained before launching
Training
- Training of all operators, production personnel on new and current improved manufacturing
processes
- Train new validation technologists to perform tasks
Troubleshooting
- Investigate and recommend effective solutions to issues arising within production
- Solving of problems through analytical processes
- Provide ongoing technical support to relevant departments
Raw material evaluation
- Evaluation of raw materials determining suitability to be used
- Specialized testing of raw material for suitability
- Submit report on any variances
- Obtain relevant authorization
Product validation
- Validation of new and current products on production line ensuring compliance as per quality
SOP
- Report on any variances
Optimization, improvement of processes
- Advise and consult on recommended changes to production process
- Assist in solving capacity problems within the factory
- Advise and respond to needs within marketing relating to product re-engineering
P a g e 8 | 11
- Obtain approval to any changes through the change control system in the manufacturing
process before implementation
- Implementation of identified and approved process changes within manufacturing by using
the CAPA and Process Compliance programs
Technical transfer – scale up
- Assists with transfer of current Aspen product processes to the site following SOP
Product development
- Deliver assistance in the manufacture of trial batches and scale-up to production batches
Other
- Maintenance of the Cleaning Validation Matrix.
- Updating and reviewing of all Standard operating procedures and plans.
- Deliver assistance to optimise cleaning processes of equipment and areas.
- Study the use of alternative cleaning/sanitising agents.
- Initiate Change Control documents as required.
- Assist to optimise process procedures and related documentation.
- Generate Cleaning and Process validation reports, reporting on all findings related to the
different processes.
- Recommend corrective/preventative actions (CAPA) relating to the validation executions and
reports.
- Investigate and recommend effective solutions to issues arising within production.
- Evaluating all CIPs, introducing newly tested CIP cleaning detergents and writing of the
standard operating procedures of each CIP programme
- Solving of problems through analytical evaluation of results.
- Provide ongoing technical support to relevant departments.
- Training of all operators and production personnel on new and current improved cleaning
procedures.
Reason for leaving: To pursue the managing position of the Validation
Department with a Global company, Johnson and
Johnson. Moving was for career growth and the company
benefits are very good.

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P a g e 9 | 11
Employer 3: Aspen Pharmacare Pty Ltd
City/Town: East London
Date: January 2007 to April 2008
Position: Validation Analyst
Duties:
- Testing of Process validation samples for the Technical support department using all
Laboratory equipment and specifications
- Ensuring all results are accurate and precise as statistical evaluation of the process is critical
for Validation purposes
- Following all specific SOP’s as required
- Writing and updating SOP’s for the department
- When finished with the tasks allocated, then following up with supervisor for additional work.
- Performing method validations according to the departments schedule
- Following up with supervisor to ensure correct data is presented
- Recommend method improvements as they are identified as potential cost or time saving
improvements
- Submitting specification changes as a result of the work performed above
- Following all departmental Safety and GMP requirements at all times
Reason for leaving: Promotion
Employer 4: Aspen Pharmacare Pty Ltd
City/Town: East London
Date: September 2006 to December 2006
Position: Finished Product Analyst
Duties:
- Testing Final products for the PE manufacturing site in the QC laboratory using HPLC,
Dissolution and AA
- Using PE’s specifications
- Liaison with PE personnel to ensure samples are delivered according to schedule
- Liaison with PE staff regarding problems experienced
- Meeting release targets to ensure Customer service is maintained
- Assisting with GMP implementation in the department, i.e. replacing old standards, etc.
- Assisting with the Lab administration functions of sample login, document control and issuing
- Out of specification investigations
- Following departmental and company policies
Reason for leaving: Promotion
P a g e 10 | 11
Employer 5: Aspen Pharmacare Pty Ltd
City/Town: East London
Date: January 2006 to August 2006
Position: Raw Material Analyst
Duties:
- Testing raw material samples for the QC laboratory using various instruments and
pharmacopoeia methods
- Ensuring timeous release of approved material for production
- Out of specification investigations
- Following departmental and company policies
Reason for leaving: Reason for leaving: Promotion
Employer 6: PK Welding and Robotics
City/Town: Port Elizabeth
Date: November 2002 to December 2005
Position: Sales Account Co-ordinator
Duties:
- Co-coordinating the sales function, the order taking process from multi-national Companies
- Ensuring delivery of Products
- Fulfilling sales Admin function
- Sourcing of Product/Product Suppliers in an International Market Place
- Ensuring good customer relationships & follow up of complaints through customer complaints
systems.
- Controlling shipping of Product
- Dealing with Importing/Shipping Companies
- Handling all debits / credits for the customer base
Reason for leaving:
Husband was promoted and had to relocate from Port
Elizabeth to East London.
P a g e 11 | 11
PERSONAL DETAILS:
Christian Names: Anna-Louise
Surname: Kriel
Birth Date: 16-June-1980
Age: 35
Gender: Female
Nationality: RSA
Employment equity: White
Marital Status: Married
Number of Dependants: 1
Health: Excellent
Smoking: Yes
Disabled: No
Residential City/Town: Cape Town
Email Address: lkriel@its.jnj.com
Landline Number: 043 709 3472
Cell Phone: 082 788 2928
Languages: Afrikaans / English
CONTACTABLE REFERENCES:
Name: Leandre Gamiet
Company: Johnson and Johnson
Position: Quality Assurance Manager
Tel: 043 709 3360
Email: lgamiet@its.jnj.com
Name: Michelle Williams
Company: Johnson and Johnson
Position: East London Site Lead
Tel: 043 709 3308
Email: mwilliams@its.jnj.com
Name: Mervyn Flugel (retired in March)
Company: Johnson and Johnson
Position: Quality Director
Tel: 083 300 1824
Name: Len de Beer (Left Aspen but was my Manager)
Company: Self Employed
Position: Technical Assurance Manager
Tel: 083 669 9296

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Curriculum Vitae - Anna-Louise Kriel

  • 1. P a g e 1 | 11 CURRICULUM VITAE Mrs Louise Kriel APPLICATION DETAILS: Position Wanted: Position Related to Quality Systems / Assurance - Validation Engineer Years’ Experience: 9 Career Level: Senior Current Monthly Salary: R45000 Expected Monthly Salary: R45000 - R50000 Preferred Areas: Cape Town Transport: Own Notice Period: 1 Months' Notice SUMMARY OF EXPERIENCE RELEVANT TO POSITION APPLYING FOR: - Quality Systems and Standards - Good Manufacturing Practices - Critical Control Parameters - Project Management - Compliance and Risk Management - Change Control Process Owner - Periodic Product Reviews - NC / CAPA - Training - Capability Studies (Cpk) - Consumer Complaints - Product Release - Audits - Housekeeping CAREER OBJECTIVES: - I would like to work for a manager that is people orientated and a leader. Someone that can mentor and help me develop myself when it is required for position or company. - I am looking for an opportunity with an established and reputable organisation that would offer me an opportunity to not only utilize my current knowledge, skills and experience, but also afford me an opportunity to gain more experience to ensure and be awarded for achievements and grow within the organisation. PERSONAL ATTRIBUTES / ACHIEVEMENTS: - My true strengths lie in my integrity, leadership, communication skills and ability to perform well under pressure. - I believe that my excellent analytical thinking skills, positive attitude, willingness to learn, initiative and problem solving skills will be a benefit to your organisation. - I understand the criticality of implementation of robust Quality Systems to ensure compliance and attain Right First Time for processes and documentation which support traceability. - Introduced and implemented Quality Systems (i.e. Personal Hygiene, Line set ups, Critical Control Points for Line Operation, Products and Packaging, IPQC testing as well as line
  • 2. P a g e 2 | 11 clearance and cleaning) in the SANPRO Department (Sanitary Napkins – Engineered product) across all the lines to ensure compliance to Systems, Quality, cGMP and Good Housekeeping) - I have an excellent understanding on the Critical Control Processes Parameters during line set up and manufacturing to ensure the adherence of products and processes to high quality attributes and final product and system specifications and understand the criticality to investigate and mitigate any risks to our consumers/customers. - I have a very strong technical and analytical background for analysing of processes and data also performance of Capabilities Studies (Cpk) for equipment and systems and final product specifications utilizing Minitab. - I can efficiently manage Projects through FPX methodology. Also use SMARTWAY - I have an excellent understanding in managing Risks i.e. to products, consumer and business and to implement Quality Systems or optimise current systems to avoid reoccurrences and to eliminate possible audit findings by being pro-active. - Can efficiently investigate Consumer Complaints, Deviation and Non-conformance utilizing the CAPA process (Corrective and Preventative Actions). - Change Control Owner for implementing changes efficiently for sustainability. - Perform final product releases to the market for sale not only when they comply with the product and packaging specification; but because of my knowledge of formulations and packaging due to my expertise in Validations can comprehend out of trends, special events and capabilities. - Fully active in Audits (MCC, Internal Audits, ISO9001, Global Johnson & Johnson JJRC Audits). - My department did not receive any repeat or new finding in the last 2015 Global Audit comparing it to the last 2011 Audit when the Validation Department was labelled as critical because of all the gaps and non-compliance. EDUCATION, TRAINING & COMPUTER LITERACY: Secondary Qualification: Matric School: Nico Malan City/Town: Humansdorp Year: 1998 Tertiary Qualification 1: B.Sc Biology Degree Institution: Potchefstroom University City/Town: Potchefstroom Year: 1999 Computer Literacy: - MS Word - Symphony - Excel - Pastel - Power Point - BAAN - Publisher - Minitab - PRIDE
  • 3. P a g e 3 | 11 EMPLOYMENT HISTORY: Employer 1: Johnson and Johnson Pty Ltd City/Town: East London Date: May 2012 to date Position: Quality Engineer - Validation Monthly Salary: R42000.00 Duties: - Directs Site Master Validation Plan activities in alignment with the regions Global Standards and follow an End 2 End approach. - Adhere to and implement where required strict Quality Systems when performing routine tasks or projects and continuously improving in line with Best Practices, cGMP to ensure compliance to expected standards. - Managing and Reporting on the following Portfolios and Programs to local site and management to ensure alignment and understanding of the expectation for each activity with regards to timing and quality attributes to consistently and reliably be audit ready and in line with the Regional Global Standards: - Product Process Validation - Cleaning Validation - Packaging Validation - Bulk Holding Time Studies - Equipment Idle time Studies - Periodic Facility and Utility Reviews Quality Systems and Procedures - Generate Quality Systems and Procedures for compliance and adherence to Global standards, Best Practices and all aspects of cGMP. - Implement and Train all on the Quality Systems implemented. - Assess sites adherence to Quality Systems and Procedures trough audits and also “on the job” monitoring when performing Process/Packaging and Cleaning Validations against predetermined Critical Control Parameters. - Document and Recommend effective solutions when required and optimisations relating to the Quality Systems for products, procedures and systems in the validation reports. Validation - Validation of new and current products, packaging, utilities and facilities in line with Acceptable Quality Limits and regulations, ensuring compliance as per quality SOP - Adherence of products to strict, robust and realistic final product specifications - Report on any variances and risk mitigation - Assess Capabilities of equipment, processes and release specifications using Minitab.
  • 4. P a g e 4 | 11 Compliance and Risk Management - Understand the importance to communicate and be transparent with regards to consumer information and comprehend the criticality to investigate, escalate and mitigate any risks to our consumers/customers and business. - Implementation of Best practices and ongoing Gap analysis against Global Standards to ensure alignment and compliance Risk and Safety Assessments and Root Cause studies - Reviewing and mitigation of potential safety risks and hazards to consumer when performing validation studies/Case Studies/Optimisations/ for Product produced, Packaging components used, Cleaning and Sanitising Methods followed, Storage Temperatures monitored. - FMEA Approach used. - Perform Root cause analysis for deviation that occurs on validated product, procedures and systems always taking into consideration the safety and health risks. - Perform Corrective and Preventative action where deviations occurred through structured systems. Training - Validation Training theoretical on a one-on-one with the relevant people and is practical assessments when conducting studies. Training also entails criticality of GMP, Best Practices and Aligning to Global Standards in line with the safety and quality commitment to our consumers. - To ensure an End 2 End process approach conduct training to ensure sustainability of changes and new processes. As part of the Quality Assurance Team always involved with the GMP training for site where required. Generating of documentation (Protocols, Reports, SOPs, Risk Assessments, Quality System Procedures) - All documentation are handled confidential and in line with a document control process - Always ensure all quality data is accurately documented and for evidence analysed and trends and risks identified and reported on. - Make sure all Master Validation plans are updated and effective - Create protocols for Process, Cleaning and Packaging validation processes, evaluations and case studies to be performed. - Generate accurate validation reports reporting on all findings related to the validation processes, evaluations and case studies and documenting any abnormalities or potential risks that may occur. - Create Standard Operating procedures for production to ensure adherence to Quality Systems. - Trending capabilities of procedures and systems through and report statistical data. - Conclude products, procedures and the reports only if under suitable control and if it can consistently meet the high quality and safety attributes expected. - Recommend effective solutions relating to the products, procedures and systems in the validation reports to conclude or optimize.
  • 5. P a g e 5 | 11 Change Control Process Owner: - Actively part of the Change Control System on site and understand the criticality of information and detail for managing and implementing changes efficiently for sustainability. Periodic Product Reviews: - Critical to ensure processes and formulas are under suitable control and that there are no risk to them taking into consideration but not limited to, batches produced, equipment used, stability, changes, trending of assays and other final product specification NC / CAPA: - Investigation of Out Of Specifications, Out of Trends, Deviations for implementation of Corrective and Preventative Actions. Projects: - Managing Projects and implementation through the FPX methodology. Also familiar with SMARTWAY. Capability Studies: - This department is a Critical part in the Quality Assurance and Quality Control departments and ensures that manufactured/packed products are of high quality and fit for our customers use. - This includes the assessing of Mixing and Line Capabilities of the equipment and product/ process specifications used utilizing Minitab and Sig ΩSigma Methodology. - This tool is to assess if a process, product, specification or limit is shifting and needs investigation to eliminate possible risk. Consumer Complaints: - How to analyze categories of complaints and mitigate any risks. Satisfying the consumer in such way to protect them, the company and the integrity of the product in the market. Product Release: - Release Products when they comply with the final product specifications and investigate out of trends taking the validation results for the product into consideration to ensure it remains within its design space and is robust. Audits: - Exposed and actively involved in audits. Preparing and implementation of Corrective actions for closure. (MCC, ISO, MRASS, Johnsons Global JJRC) Started managing department after the 2011 Global Audit and the department were labeled Critical. Received no repeat or new findings in the last Global Audit 2014 Troubleshooting - Investigate and recommend effective solutions to issues arising within production - Solving of problems through analytical processes - Provide ongoing technical support to relevant departments
  • 6. P a g e 6 | 11 Optimization, improvement of processes - Advise and consult on recommended changes to production processes. (Pharmaceutical, Cosmetics and Engineered products) - Assist in solving capacity problems within the factory - Advise and respond to needs within marketing relating to product re-engineering - Obtain approval to any changes through the change control system in the manufacturing process before implementation - Implementation of identified and approved process changes within manufacturing by using the CAPA and Symphony programs Other - Strict adherence to Standard Operating Procedures to ensure processes meets the quality standards expected consistently. - Updating and reviewing of all Product Specifications, Product Manufacturing, Packaging documentation and Standard Operating Procedures and plans. - Deliver quality and safety based assistance with to Optimisation of Manufacturing, Processes, Cleaning processes of equipment and areas and Cost Saving Projects taking in to consideration the design and what is realistic. - Adherence to all legal requirements as agreed upon and reporting any adverse events to ensure a safe environment for myself and other personnel. - Initiate Change Control documents as required. - Assist to optimise process procedures and related documentation. - Recommend corrective/preventative actions (CAPA) relating to the validation executions and reports. - Investigate and recommend effective solutions to issues arising within production. - Evaluating all CIPs, introducing newly tested CIP cleaning detergents and writing of the standard operating procedures of each CIP programme - Solving of problems through analytical evaluation of results. - Provide ongoing technical support to relevant departments. - Training of all operators and production personnel on new and current improved operational and cleaning procedures. - Performing Internal Audits - Conclude all studies with documented evidence and implement best practices where required. Reason for leaving: Husband promoted – need to relocate to Cape Town
  • 7. P a g e 7 | 11 Employer 2: Aspen Pharmacare Pty Ltd City/Town: East London Date: April 2008 to May 2012 Position: Validation Technologist Monthly Salary: R20000 Duties: Generating of documentation - Generate validation protocols on DocCompliance for Quality Assurance - Deliver assistance to optimize documentation in the manufacturing of trial batches - Effective collection of samples to ensure in process testing - Liaise with Laboratory re process testing Validation Report - Generate validation reports on DocCompliance, reporting on all findings related to the validation process - Recommend effective solutions relating the validation reports Method of manufacture - Generate standard method of manufacture documentation. - Ensure that all relevant signatures have been obtained before launching Training - Training of all operators, production personnel on new and current improved manufacturing processes - Train new validation technologists to perform tasks Troubleshooting - Investigate and recommend effective solutions to issues arising within production - Solving of problems through analytical processes - Provide ongoing technical support to relevant departments Raw material evaluation - Evaluation of raw materials determining suitability to be used - Specialized testing of raw material for suitability - Submit report on any variances - Obtain relevant authorization Product validation - Validation of new and current products on production line ensuring compliance as per quality SOP - Report on any variances Optimization, improvement of processes - Advise and consult on recommended changes to production process - Assist in solving capacity problems within the factory - Advise and respond to needs within marketing relating to product re-engineering
  • 8. P a g e 8 | 11 - Obtain approval to any changes through the change control system in the manufacturing process before implementation - Implementation of identified and approved process changes within manufacturing by using the CAPA and Process Compliance programs Technical transfer – scale up - Assists with transfer of current Aspen product processes to the site following SOP Product development - Deliver assistance in the manufacture of trial batches and scale-up to production batches Other - Maintenance of the Cleaning Validation Matrix. - Updating and reviewing of all Standard operating procedures and plans. - Deliver assistance to optimise cleaning processes of equipment and areas. - Study the use of alternative cleaning/sanitising agents. - Initiate Change Control documents as required. - Assist to optimise process procedures and related documentation. - Generate Cleaning and Process validation reports, reporting on all findings related to the different processes. - Recommend corrective/preventative actions (CAPA) relating to the validation executions and reports. - Investigate and recommend effective solutions to issues arising within production. - Evaluating all CIPs, introducing newly tested CIP cleaning detergents and writing of the standard operating procedures of each CIP programme - Solving of problems through analytical evaluation of results. - Provide ongoing technical support to relevant departments. - Training of all operators and production personnel on new and current improved cleaning procedures. Reason for leaving: To pursue the managing position of the Validation Department with a Global company, Johnson and Johnson. Moving was for career growth and the company benefits are very good.
  • 9. P a g e 9 | 11 Employer 3: Aspen Pharmacare Pty Ltd City/Town: East London Date: January 2007 to April 2008 Position: Validation Analyst Duties: - Testing of Process validation samples for the Technical support department using all Laboratory equipment and specifications - Ensuring all results are accurate and precise as statistical evaluation of the process is critical for Validation purposes - Following all specific SOP’s as required - Writing and updating SOP’s for the department - When finished with the tasks allocated, then following up with supervisor for additional work. - Performing method validations according to the departments schedule - Following up with supervisor to ensure correct data is presented - Recommend method improvements as they are identified as potential cost or time saving improvements - Submitting specification changes as a result of the work performed above - Following all departmental Safety and GMP requirements at all times Reason for leaving: Promotion Employer 4: Aspen Pharmacare Pty Ltd City/Town: East London Date: September 2006 to December 2006 Position: Finished Product Analyst Duties: - Testing Final products for the PE manufacturing site in the QC laboratory using HPLC, Dissolution and AA - Using PE’s specifications - Liaison with PE personnel to ensure samples are delivered according to schedule - Liaison with PE staff regarding problems experienced - Meeting release targets to ensure Customer service is maintained - Assisting with GMP implementation in the department, i.e. replacing old standards, etc. - Assisting with the Lab administration functions of sample login, document control and issuing - Out of specification investigations - Following departmental and company policies Reason for leaving: Promotion
  • 10. P a g e 10 | 11 Employer 5: Aspen Pharmacare Pty Ltd City/Town: East London Date: January 2006 to August 2006 Position: Raw Material Analyst Duties: - Testing raw material samples for the QC laboratory using various instruments and pharmacopoeia methods - Ensuring timeous release of approved material for production - Out of specification investigations - Following departmental and company policies Reason for leaving: Reason for leaving: Promotion Employer 6: PK Welding and Robotics City/Town: Port Elizabeth Date: November 2002 to December 2005 Position: Sales Account Co-ordinator Duties: - Co-coordinating the sales function, the order taking process from multi-national Companies - Ensuring delivery of Products - Fulfilling sales Admin function - Sourcing of Product/Product Suppliers in an International Market Place - Ensuring good customer relationships & follow up of complaints through customer complaints systems. - Controlling shipping of Product - Dealing with Importing/Shipping Companies - Handling all debits / credits for the customer base Reason for leaving: Husband was promoted and had to relocate from Port Elizabeth to East London.
  • 11. P a g e 11 | 11 PERSONAL DETAILS: Christian Names: Anna-Louise Surname: Kriel Birth Date: 16-June-1980 Age: 35 Gender: Female Nationality: RSA Employment equity: White Marital Status: Married Number of Dependants: 1 Health: Excellent Smoking: Yes Disabled: No Residential City/Town: Cape Town Email Address: lkriel@its.jnj.com Landline Number: 043 709 3472 Cell Phone: 082 788 2928 Languages: Afrikaans / English CONTACTABLE REFERENCES: Name: Leandre Gamiet Company: Johnson and Johnson Position: Quality Assurance Manager Tel: 043 709 3360 Email: lgamiet@its.jnj.com Name: Michelle Williams Company: Johnson and Johnson Position: East London Site Lead Tel: 043 709 3308 Email: mwilliams@its.jnj.com Name: Mervyn Flugel (retired in March) Company: Johnson and Johnson Position: Quality Director Tel: 083 300 1824 Name: Len de Beer (Left Aspen but was my Manager) Company: Self Employed Position: Technical Assurance Manager Tel: 083 669 9296