QC Officers – Documentation (10 positions)

Announcement Number: DB/05/2025/QC07
Position Title: QC Officers – Documentation (10 positions)
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 QC Officer Documentation is responsible for managing and maintaining all quality control documentation to ensure traceability, data integrity, and regulatory compliance within the pharmaceutical quality management system. This includes the preparation, review, issuance, archival, and control of analytical test records, Certificates of Analysis (CoAs), method validation reports, logbooks and other GMP-related documents. The officer ensures that all documentation meets the standards of ALCOA+ principles, complies with internal SOPs and regulatory guidelines (e.g., WHO, FDA, NDA) and is readily retrievable for audits and inspections. The ideal candidate should have strong attention to detail, working knowledge of cGMP and GLP and experience in document control within a regulated pharmaceutical QC setting.

Key Duties and Responsibilities:

1. Review and archive quality control records including raw data, laboratory worksheets, calibration logs and test reports to ensure compliance with cGMP.
2. Maintain accurate, up-to-date and traceable records in line with ALCOA+ data integrity principles.
3. Coordinate the preparation, issuance, control, and retrieval of laboratory documents such as SOPs, forms, protocols and specifications.
4. Track document revision histories and ensure version control is properly maintained.
5. Support document review cycles and facilitate periodic review of controlled documents.
6. Ensure proper filing, indexing and retrieval systems for easy access to quality records and regulatory documentation.
7. Participate in the preparation and collation of documents required for internal audits and regulatory inspections.
8. Assist in training laboratory staff on documentation procedures and document handling best practices.
9. Collaborate with the quality assurance and validation teams to ensure harmonized document control across departments.
10. Identify and initiate improvements in document workflows to enhance efficiency and compliance.

Academic Qualifications:

Bachelor’s degree in Pharmaceutical Sciences, Industrial Chemistry, Laboratory Technology, Information Science or a related discipline from a recognized institution.

Experience and Competencies:

1. Minimum of 2–4 years of experience in documentation control or quality systems in a pharmaceutical or regulated manufacturing environment.
2. Strong understanding of GMP, GLP, and documentation standards required by regulatory authorities (e.g., NDA, WHO PQ).
3. Familiarity with document control software and electronic document management systems (EDMS) is an added advantage.
4. Excellent organizational skills with a high level of accuracy and attention to detail.
5. Effective communication skills and the ability to collaborate across departments.
6. Demonstrated ability to manage large volumes of documentation efficiently under minimal supervision.