Job Detail

Job Description

Job Purpose

To support Quality Assurance activities across manufacturing and packaging operations by ensuring compliance with GMP, WHO, and FDA standards, with a focus on in-process control, documentation accuracy, and adherence to approved procedures.

Key Responsibilities:

1. Perform line clearance activities in manufacturing and packing areas for tablets, capsules, semi-solids, dry powders, and liquid oral dosage forms in accordance with GMP requirements.
2. Verify and approve dispensed raw materials and packaging materials prior to manufacturing and packaging operations.
3. Conduct in-process quality checks during manufacturing and packing operations to ensure compliance with approved procedures and specifications.
4. Review completed Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), and associated laboratory records for accuracy, completeness, and GMP compliance.
5. Issue, control, and reconcile BMRs and BPRs in accordance with document control procedures.
6. Assist in the preparation and review of BMR and BPR formats in line with product and process requirements.
7. Support the preparation of Process Validation protocols and reports under the guidance of senior QA personnel.
8. Assist in the preparation and execution of Hold Time Study protocols and reports.
9. Assist in the preparation and execution of Cleaning Validation protocols and reports.
10. Support the preparation of the Annual Product Quality Review (APQR) in accordance with WHO and GMP requirements.
11. Prepare, review, and update Standard Operating Procedures (SOPs) related to Quality Assurance activities.
12. Ensure adherence to data integrity principles (ALCOA+) and good documentation practices (GDP).

Skills Required

• Communication Skills
• MS Excel
• Pharmacist
• MS WORD
• quality control
• WHO