Role Summary:

The QA Documentation/GMP Officer is the gatekeeper of the Quality Management System (QMS). This role ensures that all GMP documentation (SOPs, Batch Records, Specifications) is controlled, updated, and archived in compliance with regulatory standards. This role is also responsible for promoting a "Right First Time" culture regarding documentation practices.

Key Responsibilities:

Document Control: Manage the issuance, retrieval, review, and archiving of GMP documentation, including Batch Manufacturing Records (BMRs), Standard Operating Procedures (SOPs), and test methods.

SOP Management: Coordinate the periodic review of SOPs to ensure they are current and reflect actual practices.

Logbook Management: Issue and review laboratory and production logbooks, ensuring traceability.

Training Records: Ensure that personnel training records are up to date and tied to current versions of relevant SOPs.

Quality Metrics: Track and report on document control metrics (e.g., overdue reviews, cycle times for document approval).

GMP Compliance: Perform regular walkthroughs of production/warehouse areas to ensure GMP housekeeping standards are being met (cleanliness, labeling, storage).

Support: Support QA in the preparation of documentation for regulatory inspections and internal audits.

Qualifications & Experience:

Education: Bachelor’s degree in Life Sciences, Pharmacy, or related field.

Experience: 1–3 years of experience in a GMP-regulated environment, specifically in document control.

Technical Skills: Experience with Electronic Document Management Systems (EDMS) is highly preferred. Advanced knowledge of MS Office (Word/Excel).

Key Competencies:

• Meticulous attention to detail and accuracy.
• Strong organizational and time-management skills.
• Excellent communication skills to interface with all departments.

• 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.

• 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.

• Bachelor’s degree in Life Sciences, Pharmacy, or related field.
• 1–3 years of experience in a GMP-regulated environment, specifically in document control.