2. Page 2
Personal Details
Surname: Moodaley
First Names: Nathan James
Address: 42 La Parida Crescent
Silverstone Country Estate
50 Nikkel Street
Monavoni
Centurion
Pretoria
0157
Telephone Number: (H) 084 513 4057
(W) 011 635 9089
Date of Birth: 24-01-1967
Identity Number: 670124 51 99 08 5
Sex: Male
Marital Status: Married
Health: Excellent
Home Language: English
Nationality: South African Citizen
Driver’s License: Code 8
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3. Academic Details : Senior Education
School: Woolhope Secondary School
Matriculation Year: 1984
School Certificate: Department of Education and Culture
Senior Certificate with matriculation exemption
Subjects Passed: English first language HG D
Afrikaans second language HG D
Mathematics HG C
Physical Science HG D
Biology HG D
Accounting HG D
Achievements: Represented school in soccer, tennis and cricket
Tertiary Education
1. Institution: UNISA
Degree Completed: BSc (statistics)
Courses Completed: Chemistry 101-N 102-P 103-Q
Physics 102-6 103-8
Education 100-K
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Mathematics 101-L 102-M 103-N
211-R 212-S 213-T
214-U 305-W
Statistics 102-J 101-H 111-K
112-L 202-M 203-N
204-P 206-R 211-N
207-S 302-Q 305-T
306-U 303-R 310-Q
312-S 301-P
2. Institution: NMMU (ex UPE)
Diploma Completed: Management Development Diploma Programme (MDP)-2002
Modules Completed: Basic Research Methodology; Best Human Resources
Management Practices; Contract Law; Economic
Overview; Finance for Non-Financial Managers; Health,
Safety and Environmental Management; General and
Strategic Management; Labour Relations; Leadership
and Team Building; Operations Management;
Organisational Communication; Presentation Skills;
Project Management; Purchasing and Supply Chain
Management; Self Development; Strategic Marketing;
Stress Management; Total Quality Management;
Portfolio Assessment
5. Page 5
Employment History
1. Company: Fresenius-Kabi Manufacturing South Africa(ex Bodene
(Pty) Ltd)
Period: September 1992 to October 2013
Position Held: Chemistry Laboratory Manager (since 1999)
Duties: 1. Reponsible for coordinating and allocating work.
2. Ensure the proper training of staff.
3. Coordinate all chemical testing of raw materials,
components, water, large and small volume
parenterals and intermediates with the
Supervisor ensuring accurate and timeous results.
4. Manage product and method validation, stability
programme, production and customer queries.
5. Checking and approval of new specifications,
updates to existing specifications, validations.
6. Coordinates evaluation of new raw material
suppliers and submission to RA department for MCC
approval.
7. Ensure all laboratory equipment is maintained and
calibrated regularly following the relevant
procedures.
8. Perform routine maintenance of laboratory
equipment where possible.
9. Responsible for the pricing, ordering and receipt
of all chemicals, standards, glassware,
equipment and consumables for the laboratory.
6. 10. Ensure the chemistry laboratory stays abreast
with new technology and development.
11. Ensure Good Laboratory Practice and Safety
principles are applied at all times.
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12. Involved in troubleshooting and assist where
possible in the factory.
13. Responsible for standard operating procedure
writing, review and approval in the laboratory
following ICH, SA GMP, MCC, EU, TGA, USP, BP, EP
guidelines.
14. Involved in new product development.
15. Responsible for staff discipline following the
company disciplinary procedure.
16. Responsible for handling staff administrative
matters, queries.
17. Interview and appointment of new staff members.
18. Prepare Expense and CAPEX Budget forecasts for
each financial year and monitor expenditure monthly.
19. Maintain a suitable control system, ensuring
analysis, document, standard, and equipment
traceability.
20. Ensure risks assessments, CAPA, change controls
are initiated and implemented.
21. Responsible for external and internal audits.
2. Company: Adcock Ingram Healthcare
Period: November 2013 to present
Position Held: Stability Program Manager
7. Duties:
1. Effective utilization of resources for cost
effectiveness for both chambers and testing
2. Provide input into budgeting requirements for
stability unit.
3. Liaise with internal and external customers
relating to reports on stability testing and
storage.
4. Ensure that the Stability Unit (Chambers and
testing) is operated within the scope of GLP and
cGMP practices as well as in accordance with OSH
Act and MCC regulations. The scope of compliance
for the testing and storage facility includes FDA,
WHO, MCC regulations and adherence to ICH
guidelines
5. Setup and implement SOP’s and processes for the
Stability department
6. Controls and procedures for both storage and
testing units are current and compliant
7. To coordinate test schedules with lab capacity and
ensure stability testing and reports are completed
to plan.
8. Evaluate, discuss and /or problems solve stability
lab reports, out- of- specification investigations
and out-of trend analysis using laboratory best
practices
9. Report on trial test status, out- of-
specification investigations and out-of trend
analysis.
10. Final approval of reviewed, evaluated and
trended data
11. Liaise with the Quality Assurance site managers
on the changes affecting product related to
stability of the product via Stability Forum Site
meetings.
12. Schedule testing and storage in terms of
project timelines and trial status.
13. Implement best operating practices and
continuous improvement.
Experience: Twenty three years’ experience in Pharmaceutical
laboratory. Highly experienced in chemical analysis
and instrumentation including HPLC and AA.
Experience in staff supervision and managing a
laboratory. Experience in Analytical Method
Development, Specifications, Stability and
Validation. Knowledge of ISO 9002 and International
quality systems.
8. Page 7
Other Activities and Achievements
1. Successfully completed Microsoft Access (Basic) course
2. Successfully completed Millennium and Empower HPLC
advanced course
3. Successfully completed Management Development
Programme through UPE
References
1. Mr. A Weelson
ex QC Manager
Bodene (Pty) Ltd
Tel: 083 987 5504
2. Mr. P Rautenbach
ex QA Manager
Bodene (Pty) Ltd
Tel: 041 407 2111
3. Saadia Chapple
Head of QC Laboratory
Adcock Ingram Healthcare
Tel: 011 635 9144
