Background

The NARO Vaccine and Pharmaceuticals Centre (NVPC) is a specialized Centre of the National Agricultural Research Organisation (NARO) responsible for research, development, production and commercialization of vaccines, pharmaceuticals and other products of strategic importance to animal health and agricultural development.

In line with the Centre’s strategic objectives and the need to ensure effective implementation of its programs and activities, the Centre is seeking competent, innovative, results-oriented and suitably qualified candidates with the relevant knowledge, skills and experience to contribute to the achievement of its mandate and strategic objectives. Employment terms for all positions are contractual and the duty station is NVPC, Nakyesasa, off Gayaza-Zirobwe Road.

Job Purpose

To provide independent QA oversight of laboratory systems, testing processes, laboratory documentation and laboratory data to ensure that laboratory activities supporting product quality decisions comply with GMP and data-integrity requirements and any other non-routine Quality Assurance work objectives.

Specific responsibilities

The specific tasks of the successful candidate will be to:

• Provide QA oversight of QC laboratory operations and GMP compliance.
• Review and approve laboratory SOPs, specifications, analytical procedures and controlled laboratory documents.
• Verify implementation of approved laboratory procedures.
• Review laboratory records for completeness, traceability and compliance.
• Provide QA oversight of 0OS/OOT investigations.
• Review laboratory deviations and related CAPA.
• Review analytical method validation/verification documentation from a QA perspective
• Provide QA oversight of laboratory equipment qualification and computerized laboratory systems.
• Review laboratory computerized-system validation documentation.
• Verify sample traceability from receipt through testing and reporting.
• Review environmental-monitoring results and trends from a QA perspective.
• Review critical laboratory quality trends and escalate adverse trends.
• Provide QA input into product release decisions based on laboratory documentation and results.

Minimum Academic Qualifications and Experience

Applicants should possess;

1. A Bachelor’s degree in Pharmacy, Microbiology, Biochemistry, Biomedical Sciences, Chemistry or a related science discipline.
2. Hands-on experience In Quality Assurance, Quality Control laboratory operations or pharmaceutical laboratory quality systems.
3. Strong understanding of GMP, laboratory quality systems, 00S/00T, deviations, CAPA and change control.
4. Knowledge of analytical method validation/verification, equipment qualification and computerized laboratory systems.
5. Strong understanding of data integrity principles applicable to laboratory operations.
6. Knowledge of applicable pharmacopeial and regulatory requirements, including European Pharmacopoeia, WHO GMP and ICH guidelines.
7. Experience in pharmaceutical, vaccine, biologics or other regulated manufacturing environments.
8. Experience supporting GMP audits, regulatory inspections and laboratory investigations.
9. Strong documentation, review, analytical and problem- solving skills.

• Provide QA oversight of QC laboratory operations and GMP compliance.
• Review and approve laboratory SOPs, specifications, analytical procedures and controlled laboratory documents.
• Verify implementation of approved laboratory procedures.
• Review laboratory records for completeness, traceability and compliance.
• Provide QA oversight of 0OS/OOT investigations.
• Review laboratory deviations and related CAPA.
• Review analytical method validation/verification documentation from a QA perspective
• Provide QA oversight of laboratory equipment qualification and computerized laboratory systems.
• Review laboratory computerized-system validation documentation.
• Verify sample traceability from receipt through testing and reporting.
• Review environmental-monitoring results and trends from a QA perspective.
• Review critical laboratory quality trends and escalate adverse trends.
• Provide QA input into product release decisions based on laboratory documentation and results.

• Strong understanding of GMP, laboratory quality systems, 00S/00T, deviations, CAPA and change control.
• Knowledge of analytical method validation/verification, equipment qualification and computerized laboratory systems.
• Strong understanding of data integrity principles applicable to laboratory operations.
• Knowledge of applicable pharmacopeial and regulatory requirements, including European Pharmacopoeia, WHO GMP and ICH guidelines.
• Strong documentation, review, analytical and problem- solving skills.

• A Bachelor’s degree in Pharmacy, Microbiology, Biochemistry, Biomedical Sciences, Chemistry or a related science discipline.
• Hands-on experience In Quality Assurance, Quality Control laboratory operations or pharmaceutical laboratory quality systems.
• Experience in pharmaceutical, vaccine, biologics or other regulated manufacturing environments.
• Experience supporting GMP audits, regulatory inspections and laboratory investigations.