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MATHIAS FOWUNG ATELEFACK
3434 Carriage Hill Circle #201
Randallstown MD 21133
Tel: 4432265132 (Cell)
4107018662 (Home)
Email: mfatelefack@hotmail.com
Skype: mathias.atelefack
SUMMARY:
 A highly qualified laboratory scientist with over 20 years of experience in FDA regulated laboratories in the
Pharmaceutical and Biotechnology industries.
 Extensive QA/QC experience in overseeing the cGMP manufacture of 4 different kinds of capsules (antibiotics), 12
different kinds tablets of diverse therapeutic classes,5 different kinds of liquid syrups, 6 different kinds of dry powdered
syrups (anitibiotics), 4 different kinds of suspensions and cardiac stents. Both brand and generic products.
 Coordinated an elaborate distribution network (GDP) of manufactured pharmaceuticals to the following countries
within the CentralAfrican Region: Cameroon, Gabon, CentralAfricanRepublic, Congo Brazzaville, Equatorial Guinea,
Chad and part of Nigeria. Products were manufactured in Douala, Cameroon.
 Versed with the 21 Code of Federal Regulations (CFR) 11, 58, 210, 211 and 820 for class two medical devices.
 Comfortable with the review of retrospective,propective and concurrent processvalidation data with statistical analysis.
 Used the United States Pharmacopoeia (USP/NF), the British Pharmacopoeia (BP), the French Pharmacopoeia (FP),
the European Pharmacopoeia (EP), and the Merck Index
 Comfortable using the concepts of ICH Q7 GMPs for APIs,IPEC GMP guide for pharmaceutical excipients and ISO
13485 standards for class two medical device
 Good understanding of capacity building and strengthening of laboratory medicine in resource-limited settings for
PEPFAR funded projects
 Developed an External Quality Assessment Center (EQA) for the monitoring of quality testing in clinical laboratories
for the Federal Government of Nigeria – total of 900 labs currently enrolled. A PEPFAR funded project
 Familiar with USG/PEPFAR funded projects for capacity building
 Comfortable and knowledgeable in working with health officials in resource limited settings
 Comfortable working with people of diverse cultural backgrounds
 Experience with the Laboratory Information Management System (LIMS) as well as the Empower2 Chromatography
software
 Worked with diverse laboratory equipment such as HPLC, GC-FID, UV-VIS, FTIR, Dissolution systems, balances,
automatic titrators (KF),viscometer, polarimeter, pH meter, Thin Layer/ Column chromatography and glassware,CD4
FacsCounter, Western Blot and ELISA analyzers, Amplicor Monitor for viral load testing
EXPERIENCES:
January to July 2016
SR. QA Specialist, Laboratory Control, Sancilio & Company Inc. Riviera Beach, Fl.
Provide quality oversight for analytical laboratory operations and work collaboratively with the site management and
analytical laboratory personnel to assure adherence to regulations, guidelines and standards.
 Provide quality oversight of all aspects of analytical laboratory operations.
 Provide timely and accurate review of analytical data packages.
 Participate in laboratory investigations, customer complaints and vendor complaints and make recommendations for
corrective and preventative actions, and to follow up on the implementation of those recommendations.
 Approve GMP documentation, including SOP’s,specifications, test methods, test method and cleaning
verification/validation protocols and reports, change controls and other controlled documents.
 Conduct periodic stability data reviews and analyze data for trends.
 Provide QA oversight and guidance for the development and implementation of diverse laboratory SOPs related to
equipment and cleaning validations, IQ,OQ and PQ of analytical equipment, calibrations and general
chromatographic techniques and data acquisition. Data integrity concepts and review.
 Develop and maintain a laboratory self-inspection program and conduct routine inspections.

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 Interact and provide company representation to regulatory bodies relating to Quality Assurance and Laboratory
Compliance.
August to December 2015
Senior QA/QC Data Reviewer, Mylan Laboratories, Nashik, India (Consultancy)
Provide consulting support around regulatory commitments related to retrospective review of legacy investigations, with
focus on assessing adequacy of GMP-documentation - where appropriate, such investigations will be further evaluated
and prioritized, further investigated and reviewed, including evaluation of product impact, root cause and corrective
actions. The duties have several functional areas of focus:
 Quality Control and/or Analytical Chemistry - OOS/OOT,chromatography and associated electronic data packets
(identifying incomplete or the absence of required investigations within this data system). Emphasis was on the
retrospective evaluation of inhibit integration parameters applied in related substances/chromatographic purity tests
for sample chromatograms
 Quality Assurance - Complaint investigations, manufacturing deviation investigations, supplier investigations,
laboratory investigations etc. Perform due diligence in the investigation of complaints related to drug ineffectiveness
through the reviews of Annual Product Reviews (APR)/ Product Quality Reviews (PQR) and the different operations
that go into the production of complaint products.
This facility manufactures 276 solid dosage generic forms for the following markets – Japan, the United States,Australia,
New Zealand and the European markets. Prepared daily reports for trend analysis
June 2014 to May 2015
Senior Manager, Data Integrity Audits, Pfizer Inc.
Assist the Corporate Compliance audit group in performing risk based audits, mock inspections, assessments,data
integrity audits and routine quality systems audits of Hospira’s manufacturing sites located in Asia, Europe and the United
States. Hospira is the global leader in the manufacture of injectables and some medical devices. Used the SAP DMS and
the TrackWise extensively for these operations.
 Provide assurance that data generated during operations is accurate and that all results reported are a true
representation of the quality of Hospira products.
 Working with Corporate Compliance Auditing and site internal audit to review audit reports and responses and to
personally audit for discrepancies between data, including computerized systems data, or information identified in
approved applications, and the actual results, methods, or testing conditions submitted to regulatory authorities or
performed for customers that may have been used to support submission to the agency.
 Identification of past, current or future periods during which inaccurate data reporting occurred at Hospira facilities
 Identification and interview of current employees employed prior to, during, or immediately after the relevant
period(s) to identify activities, systems, procedures and management behaviors that may have resulted in or
contributed to inaccurate data reporting
 Identification of former employees who departed prior to, during, or after the relevant periods and to make diligent
efforts to interview them to determine whether they possess any relevant information regarding any inaccurate data
reporting
 Determination of additional evidence to support information gathered during interviews, and whether additional
facilities involvement in or affected by inaccurate data reporting
 Utilization of organizational charts and SOPs to identify specific managers in place when inaccurate data reporting
occurred and to determine the extent of top and middle management involvement in, or awareness of data
manipulation
 Determination if individual managers identified above are still in a position to influence data integrity with respect to
regulatory requirements or the submission of applications; and to establish procedures to expand internal review to
any other facilities determined to be involved in, or affected by, the inaccurate data reporting
 Preparation of reports highlighting observations in the course of these functions.
Accomplishments
Successfully participated in the quality systems audit of:
 A manufacturing site located in India in preparation of an FDA inspection
 Manufactureing facility in Austin, Texas
 Manufacturing facility in McPherson, KS
 Manufacturing facility in Rocky Mount, NC

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 Global Stability Operations – Global function (Lead Auditor)
 Global Information Technology – Global function
 Global Distribution Operations – Global function
 Global Documentation and Labeling Operations – Global function
 Deviation and CAPA management for medical devices
July 2011 to May 2014
Senior Quality Professional/Lead Auditor (Consultant), SQA Services Inc. Rolling Hills,Ca
Conduct external/vendor audits and recommend supplier suitability and site rating.
Worked with diverse vendors to develop a quality systems audit checklist based on J&J specifications.
Planned and conducted audits of J & J’s quality system to ensure conformance with the Quality System Regulation (QSR)
- 21 CFR part 7, 11, 58, 210 & 211 and applicable Corporate and site Policies/Procedures
Developed a remediation plan to correct identified audit gaps leading to CAPA closures in key quality systems and
subsystems such as: the development of a quality manual/policy, buildings and facilities, laboratory and process equipment,
documentation and records, materials management/distribution, production and process controls, packaging and labeling,
laboratory controls, validations (prospective, concurrent and retrospective), change control (equipment and processes),
investigations, customer complaints and recalls using ICH Q7 guidelines and IPEC guides
Participated with the Corporate Audit Support Team to help provide corporate audit support to sites undergoing notified
body inspections (primarily FDA audits)
Accomplishments:
Performed the following quality systems audits, nationally and internationally:
 ROPACK pharmaceuticals, a secondary packaging company in Montreal for an SQA client, (Lead Auditor)
 The International Flavor & Fragrance company – a chemical plant (Lead Auditor)
 Atrium Innovations – an API manufacturer located in Canada (Lead Auditor)
 Kronos Canada – manufacturer of TiO2 (Lead Auditor)
 RockTenn Packaging Company, Quebec, Canada (Lead Auditor)
 St. Johns Packaging Company, Montreal, Canada (Lead Auditor)
 SILGAN Plastics, Montreal, Canada (Lead Auditor)
Worked with 10 diverse suppliers to J&J in developing and implementing corrective and preventive actions (CAPA) that
addressed audit observations – suppliers for both APIs and excipients. Developed diverse SOPs for each of the suppliers
as well as provide training modules along GMP guidelines for both analytical and production staff
Conducted on the spot effectivenesschecksfor the appropriate implementation of the recommended corrective actions prior
to signing off for closure and change is the site’s rating
September 2013 to Decenber 2013
Fresenius Kabi Oncology Limited, Kalyani, India - API Manufacturer, Under Consent Decree: (Consultancy)
 Provided QA/QC oversight to the testing process of excipients, in-process materials and finished products.
 Assist in the review of analytical test methods
Accomplishments
 Data review generated by HPLC,FTIR, GC-FID, UV-VIS,Karl Fischer, Polarimeter, viscometer and extensive wet
chemistry data. Review was to authenticate integrity of a backlog of data which was the cause of the consent decree
situation after an FDA audit which identified lapses in the integrity of the data generated in their laboratory testing
processes
 Review of raw analytical data generated by the HPLC and GC-FID for system suitability criteria, integration
parameters,manual calculations on theoretical plates and tailing factors. Review of archived laboratory log books and
work forms.
 Identified grey areas in most test methods which gave room for scientists to carry out tests in a less restricted manner.
Made recommendations for the revision of test methods and the management of laboratory operations
 Equipment calibration program
 Mentoring of the QC staff – managers,supervisors and analytical chemists
 Assist in the conduction of an elaborate laboratory investigations which involved the interviewing of laboratory
scientists and supervisors on the conduct of laboratory tests and data reporting and the proposal of the appropriate
CAPAs
 Perform data review for product releases in the SAP system

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 Make recommendations on laboratory supplies to improve testing
 Act as liaison in the coordination of samples sent to outside laboratories for testing.
Coordinate the sampling process for all raw materials, in-process samples and finished product and their
movement/documentation through the testing process
September 2010 to June 2011
Laboratory Manager, Axios Foundation Inc. Cleveland, Ohio (Consultancy)
National Laboratory for External Quality Assessment, Zaria, Nigeria
The National Laboratory for External Quality Assessment Centre (NLEQAC) is a reference centre of excellence working
towards WHO/AFRO accreditation. The External Quality Assessment program (EQA) which the centre coordinates is an
essential feature of systems designed to maintain and improve the analytical quality of clinical laboratory tests within the
country of Nigeria for the treatment and management of HIV/AIDS patients.
Accomplishments: Building ofLocal Capacity along these lines
 Site organization as in the design of an organogram and a quality statement which commits management to ensure
compliance with the Principles of Good Clinical Laboratory Practice (GCLP).
 Recommended and worked with diverse manufacturers of laboratory equipment and reagents for the purchases of these
items for the laboratory.
 Designed maintenance agreements and regular supply of accessories with the manufacturers of these equipment for
their smooth functioning.
 Worked with manufacturers of these equipment to train local personnel for emergency interventions when needed
 Laboratory description, activities and investigations. Design detailed job descriptions for staff on site.
 Listing of laboratory equipment with detailed history of each, which included maintenance policy and history,
procurement policy, monitoring of instrument performance and the management of instrument calibrations. Review
validation data generated for all laboratory equipment for completeness and compliance with the manufacturers’
specifications – this included IQ, OQ and PQ.
 Delivered diverse training ranging including Good Laboratory Practice (GLP),Good Documentation Practice (GDP),
Laboratory Investigations (LI) and four laboratory safety training modules.
 Development of diverse Standard Operating Procedures (SOPs),Quality and Safety policies, specifications, forms and
diverse worksheets and logbooks.
 Pull together contact information for 183 laboratories for the design of an excel database to be used for the PT
evaluations, communication with the different laboratories and a feedback loop for problems and suggested CAPAs.
 Liaised with two panel manufactures in South Africa for the smooth transfer of panels to the center which was
subsequently distributed to the 11 Implementing Partners (IPs) for distribution to their individual laboratories.
 Produced a comprehensive report on the first set of panels received with detailed statistical analysis of the laboratories’
performance for submission to the Centre for Disease Control (CDC) and the Government of Nigeria.
 Carried out a quality systems audit of 10 laboratories that did not perform well in the proficiency testing exercise
March – June 2010 Consultant Auditor,
Institute ofHuman Virology, University ofMaryland School ofMedicine,Baltimore
Carried out a Quality Systems audit at 10 Anti-Retroviral Therapy (ART) laboratories in preparation for the WHO-AFRO
5 star accreditation at the Institute of Human Virology Nigeria (IHVN)
Accomplishments: Building Local Capacity along these lines.
Provided handas-on technical guidance to all the laboratories to help remdiate audit gaps to bring the labs into compliance
The 10 laboratories which are part of a chain of 50 laboratories are located in Abuja, Benin, Jos, Kano, Zaria and Lagos
are part of a USAID/PEPFAR funded project for IHV. Using the elements of the WHO-AFRO checklist for this exercise,
which are based on ISO 15189:2007(E), and to a lesser extent on the Clinical and Laboratory Standards Institute (CLSI)
guideline GP26-A3. CLSI has identified Quality Systems Essentials (QSEs), which together with ISO 15189 constitutes
the principal components used to establish a quality management system for diagnostic laboratories. Audit looked at the
state of laboratory equipment for adequacy to the kinds of test performed, calibrations and maintenance records, storage
conditions of reagents and quality agreements with suppliers.
September 2009 – February 2010
Senior Quality Assurance Associate, Pharmaceutical International Inc. (Consultancy)
Hunt Valley, MD

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 Ensured the timely and accurate inspection of rawmaterials, in-process blends and finished drug product while adhering
to cGMP and ICH guidelines as well as USP/NF/EP/JP/Health Canada, and other regulatory statutes, as written
 Perform “Line Clearance” and “Cleaning Verification” for manufacturing and packaging operations per established
Standard Operating procedures and batch/Packaging and labeling Records’ requirements
 Perform in-process sampling, inspections, testing, and batch record reviews during manufacturing and packaging
operations as per established SOP
 Perform Acceptable Quality Level (AQL) sampling and testing as required for in-process and finished product
 Participated in the preparation for sampling, actual submission of samples to Quality Control (QC) and disposition of
samples for cleaning verification
 Perform daily systems verifications including ,but not limited to, recording and reporting of magnehelic gauge data and
water systems data and the disposition of the systems
 Participated in and supported Annual Product Reviews (APRs)Create storage systemsfor storage and retrieval of retain
samples as required
 Reviewed quality systems, including policies and procedures, and recommended improvements affecting compliance
and efficiencies
 Used the SAP system in all these functions and duties
September 2005 – July 2009
Senior Quality Assurance Associate, UPM Pharmaceuticals of Maryland
(Contract manufacturer for clinical and commercial products), Baltimore, Maryland
 Responsible for the review and issuance of manufacturing and packaging batch records for the manufacture of clinical
and GMP products – capsules, tablets and suspensions
 Generation, issuance and reconciliation of labels for clinical and commercial samples
 Review of executed manufacturing and packaging batch records of the above products
 Review of diverse analytical data for accuracy and compliance with cGMP and the company SOPs prior to allowing
formal company release for manufacturing activity
 Responsible for the review of diverse analytical validation protocols and reports
 Review of stability protocols and reports for trends. Review of stability inventory for data entered as well as stability
chambers for temperature and humidity excursions and impact assessment on stored samples
 Had the authority to reject or release a product or manufacturing equipment based on sound scientific judgment
 Review of data for products tested by contract laboratories. Review laboratory and manufacturing specifications,
equipment qualifications for accuracy and compliance with cGMP, GLP and company SOPs.
 Handled deviations and investigations arising from the laboratory or manufacturing for proper closure with the
appropriate CAPA
 Coordinated diverse change control (Planned changes and Emergency changes) projects related to Facilities (new
constructions, utilities, repairs and improvements), equipment and Instruments (including analytical instruments that
are assessed for Change Control), Changes or repairs to existing equipment, Production processes and Changes to
controlled documents
 Maintained and updated the database for all reviews on a daily basis. Conduct internal and external audits of vendors
 Provide cGMP and safety training to personnel
 Used the DOCUMENTUM software for the execution of all these functions
 Put together reports and data packages for diverse clients for their NDA submissions to regulatory bodies in different
countries (Israel and New Zealand) including the FDA
January- December 2004
Senior Quality Assurance Auditor/ Training Consultant, Cordis LLC, (Consultancy) Puerto Rico
Data reviewer for stability indicating assay and impurities for cardiovascular stents, residual solvent analysis, and
dissolution data for the final disposition of lots. Part of a team of Training Consultants, participated in the development and
deliverance of the following Training modules to 45 chemists:
 Glassware & Volumetric Measurements
 Handling of Analytical data- the significant figures convention and rounding of numbers
 Making measurements and reporting – GLP, Quality Control and Charting
 Monitoring of laboratory methods

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 Sample preparation and Handling – Keeping sample integrity
 Laboratory Investigation – Increasing laboratory investigation effectiveness
 Karl Fisher Titration
 Gravimetric Training module – Appropriate use of Balances
 Introduction of Dissolution Testing
 Determination of pH in the analytical laboratory and Introduction to Titrimetry
 Spectrophotometry – UV-VIS and FTIR. Theory, Techniques and use
 Introduction to Chromatography – HPLC & GC. Separation Theory, Instrument components, Reverse phase HPLC,
Gradient and Isocratic runs, GC headspace analysis
 Chromatography – System Suitability and Integration
December 1990 - February 2002
ManagerofLaboratory Services, Rhone-Poulenc Santé Industries(ContractManufacturerfor Pfizer, Bristol-Myers
Squibb, Aventis and Roche Pharamaceuticals) Cameroon
Contract manufacturer of brand products for diverse tropical diseases supplied to the following countries: The Central
African Republic, Congo Brazaville, Gabon, Nigeria, Chad and Equatorial Guinea
 Responsible for writing laboratory SOPs.
 Responsible for testmethod validation and the review of equipment IQ/OQ/PQRelease testsforall processcomponents
 Warehouse supervision for the receipt, arrangement, storage and release of components and products- first in first out
(FIFO)
 Responsible for all lab notebooks, sample retention room and the archiving of retains
 Provide training to chemists and new hires
 Responsible for the procurement of laboratory equipment and reagents - reagents included more than 150 chemical
substances and diverse organic and inorganic solvents
Management Experience:
I directly supervised two senior chemists, two junior chemists and one senior microbiologist analyst. They all provided me
with technical support particularly related to testing, warehouse management data input from chromatographic data
systems.
Accomplishments
Successfully coordinated the technical transition from brand production to generic manufacturing through the successful
submission of drug product applications for 15generic products. This greatly improved the company’s profit margin without
any compromise to the quality of products.
OTHER EXPERIENCES:
 Attended the 11th annual GMP Conference which was sponsored by the University of Rhodes Island College of
Pharmacy, August 28-30, 2006 (USA).
 Trained on the laboratory aspects of HIV/AIDS diagnosis and the pharmacovigilance of diverse Anti Retrovirial Drugs
on HIV/AIDS patients at the Virology Laboratory of the US Center for Disease Control and Prevention – 01/00 to
12/00. Pharmacovigilance involved the monitoring and collection of patient data for the following clinical test
parameters
o Viral load quantification by the Amplicor Monitor test (Manual and the COBAS automated system)
o CD4 count
o Blood chemistry (Uric Acid Values, Blood Urea Nitrogen (BUN) Levels, Creatinine Values, Aspartate Amino
Transferase (AAT) Levels, Alanine Amino Transferase (AAT) Levels
o Any side effects or unusual manifestation
o Trend analysis of collected data
Laboratory techniques related to HIV/AIDS research
HIV serologic diagnostics by ELISAs and Rapid test
Diagnostic RT-PCR Testing on filter paper and PBMCs)
Diagnostic DNA PCR Testing
EDUCATION:
1989 Bachelor of Science degree in Biochemistry
Fluent in English and French

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Computer Skills: Microsoft Office XP professional, LIMS and Empower2, the SAP system,the DOCUMENTUM software
and the TrackWise system
Affiliation: Member of the American Society for Quality
Certifications: Certified Quality Auditor – SQA Services Inc