Quality Assurance Officer (Number of positions: 06)

Announcement Number: DB/05/2025/QA02
Position Title: Quality Assurance Officer (Number of positions: 06)
Opening Period: 05/05/2025 – 05/12/2025
Series/Grade: L (3)
Salary: Competitive
Who May Apply: All Interested Applicants
Duration Appointment: Indefinite, subject to successful completion of probationary period
Supervisory Position: None

Job Summary:

The Quality Assurance Officer is responsible for ensuring compliance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and internal quality systems across all stages of pharmaceutical production. The role involves reviewing batch manufacturing records (BMRs), overseeing in-process controls, coordinating deviation and CAPA management and supporting validation, qualification and audit readiness activities. The QA Officer also plays a critical role in the issuance and control of GMP documents, change control processes and internal training support. The ideal candidate should possess a strong understanding of regulatory standards (e.g., WHO, NDA, US FDA), quality systems implementation and operational oversight in a GMP-regulated pharmaceutical environment.

Key Duties and Responsibilities:

1. Review and approve batch manufacturing and packaging records for accuracy and GMP compliance.
2. Conduct in-process quality assurance checks during manufacturing and packaging operations.
3. Participate in the investigation and closure of deviations, OOS, OOT and complaints in coordination with cross-functional teams.
4. Monitor and enforce adherence to cGMP, GDP and internal SOPs on the production floor.
5. Support validation and qualification activities including facility, equipment, utilities and processes.
6. Manage change controls, CAPAs, and document revision workflows within the QMS framework.
7. Participate in internal audits and assist with external audits by regulatory agencies and clients.
8. Maintain accurate and traceable quality documentation and records in line with ALCOA+ principles.
9. Train and sensitize operational staff on quality systems, SOPs, and GMP awareness.
10. Promote a culture of continuous improvement and operational excellence in quality management.

Academic Qualifications:
Bachelor’s degree in Pharmacy, Industrial Chemistry, Quality Management, or a related scientific discipline from a recognized institution.

Experience and Competencies:

1. Minimum of 3–4 years of experience in pharmaceutical quality assurance within a GMP-regulated facility.
2. Proficiency in reviewing BMRs, handling deviations, CAPAs, and change controls.
3. Sound understanding of ICH guidelines, WHO GMP, and other international regulatory frameworks.
4. Strong organizational, communication, and analytical skills.
5. Proven ability to work collaboratively with cross-functional teams and under minimal supervision.