KPI is looking for a qualified Quality Assurance Officer, in charge of IPQA/GMP Monitoring, Dispensing, monitoring of Raw Materials and Packaging Materials, FGS stores, Utilities / Services, AHU Areas, and housekeeping.

Key Deliverables

1. Inspecting all manufacturing areas, equipment and systems including housekeeping daily to ensure that they comply with cGMP in all aspects of suitability of manufacturing medicines.
2. Monitor and ensure that there is proper and correct documentation of all production activities and records are updated online.
3. Review BMRs online to verify that all production stages have been completed in accordance with SOPs and all signatures and dates of persons performing and checking activities are in place.
4. Monitoring and controlling of manufacturing environment including housekeeping practices which include personal hygiene and cleanliness of manufacturing premises.
5. To approve or reject equipment/ machinery based on qualification processes.
6. To approve or reject processes based on process validation.
7. Monitoring compliance with cGMP requirements.
8. Carrying out In-process Quality Control Checks like friability, uniformity of mass, disintegration tests, moisture content, hardness, and thickness tests of all products.
9. Calibration and Qualification of all production equipment.
10. Monitoring and ensuring that the environmental conditions like temperature, pressure and relative humidity are within specifications hence don’t affect the quality of the products.
11. Ensuring safety of personnel during manufacturing and packaging.
12. Monitoring and ensuring good documentation practices are complied with throughout GMP documentations.
13. Identifying, and investigation of deviations in manufacturing processes.
14. Observing preventive maintenance, qualification, calibration programs of production equipment, systems and In Process laboratory equipment.

Qualifications and Experience:

• Bachelor of Science Technology- chemistry/ BSc. Chemical Engineering / BSc. Industrial chemistry or BSc. Pharmaceutical sciences, B.Pharmacy.
• At least 3 years’ experience in QA / QC Operations. Experience in pharmaceutical manufacturing environments will be an added advantage

Skills / Competencies:

• Basic QA/QC Knowledge
• Analytical Skills
• Flexibility
• Team player
• Attention to Detail