Job Detail

Job Description

Job Purpose

To ensure that all manufacturing, validation, and quality assurance activities are conducted in full compliance with GMP, WHO, and FDA regulatory requirements, and to maintain the integrity, safety, and quality of pharmaceutical products.

Key Responsibilities:

1. Lead and oversee In-Process Quality Assurance (IPQA) activities in accordance with GMP, WHO, and FDA guidelines.
2. Manage the Quality Management System (QMS), including deviations, change control, incidents, CAPA, and Out-of-Specification (OOS) investigations.
3. Plan, execute, review, and approve Process Validation protocols and reports in line with regulatory expectations.
4. Plan, execute, and document Cleaning Validation activities to ensure compliance with GMP standards and product safety requirements.
5. Prepare, review, and approve Annual Product Quality Review (APQR) reports in accordance with WHO TRS and FDA requirements.
6. Conduct and document Hold Time Studies, ensuring scientific justification and regulatory compliance.
7. Prepare, review, and control Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) to ensure accuracy, traceability, and data integrity.
8. Coordinate and manage qualification activities, including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
9. Lead and support internal audits, external audits, and regulatory inspections (WHO, FDA, local authorities), ensuring readiness and effective follow-up of CAPAs.
10. Review and approve specifications, analytical methods, validation documents, and quality control reports to ensure compliance with GMP and regulatory standards.
11. Prepare, review, and control Risk Assessments.
12. Ensure compliance with data integrity principles (ALCOA+) and continuous improvement of quality systems.

Skills Required

• Communication Skills
• Pharmacist
• quality
• control system