QA Documentation / GMP Officer

Job Details

The QA Documentation / GMP Officer is the gatekeeper of the Quality Management System (QMS) for a leading pharmaceutical manufacturing company, recruited via Apeiron Consultancy Ltd. The role ensures that all GMP documentation (SOPs, Batch Records, Specifications) is controlled, updated, and archived in compliance with regulatory standards and promotes a "Right First Time" culture regarding documentation practices. Duty station is Kampala, Uganda. Employment Type: Full-time. Work Hours: 8. Salary: Not Disclosed.

Key Duties and Responsibilities

• Manage the issuance, retrieval, review, and archiving of GMP documentation, including Batch Manufacturing Records (BMRs), Standard Operating Procedures (SOPs), and test methods.
• Coordinate the periodic review of SOPs to ensure they are current and reflect actual practices.
• Issue and review laboratory and production logbooks, ensuring traceability.
• Ensure that personnel training records are up to date and tied to current versions of relevant SOPs.
• Track and report on document control metrics (e.g., overdue reviews, cycle times for document approval).
• Perform regular walkthroughs of production/warehouse areas to ensure GMP housekeeping standards are being met (cleanliness, labeling, storage).
• Support QA in the preparation of documentation for regulatory inspections and internal audits.

Qualifications, Skills and Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, or related field.
• 1–3 years of experience in a GMP-regulated environment, specifically in document control.
• Experience with Electronic Document Management Systems (EDMS) is highly preferred.
• Advanced knowledge of MS Office (Word/Excel).
• Meticulous attention to detail and accuracy.
• Strong organizational and time-management skills.
• Excellent communication skills to interface with all departments.