Job Title: Quality Assurance Officer
Organisation: Kampala Pharmaceutical Industries
Duty Station: Kampala, Uganda
About Organisation:
Kampala Pharmaceutical Industries (1996) Ltd (KPI) is a part of the Aga Khan
Development Network (AKDN) and a leading pharmaceutical manufacturer in the
East African Region.
Job Summary: We are recruiting a Quality Assurance Officer who will be working in the Quality Assurance Department
Key Duties and Responsibilities:
- Monitoring compliance with cGMP requirements by Inspecting all manufacturing areas, Equipment and systems daily, to ensure that they comply with cGMP in all aspects of suitability of manufacturing medicines.
- Monitor and ensure that there is proper and correct documentation of all production activities and records are updated online.
- 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.
- Monitoring and controlling of manufacturing environment including housekeeping practices which include personal hygiene and cleanliness of manufacturing premises.
- Prepare Qualification Protocols, Perform Equipment Qualification (DQ/IQ/OQ/PQ/RQ) and approve or reject equipment/ machinery based on qualification processes.
- Prepare Process Validation Protocols, Perform Process Validation and approve or reject processes based on Process Validation Reports.
- Carrying out In-process Quality Control Checks like friability, uniformity of mass, disintegration tests, moisture content, hardness, and thickness tests of all products.
- 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.
- Reviewing completed Batching Manufacturing Records: This includes In-process Quality control records and laboratory batch testing records for completeness.
- Identifying, and investigation of deviations in manufacturing processes.
- Document control and record keeping: This includes filing, archiving, and maintaining a robust documentation system for all GMP documents.
- Writing and maintaining SOPs: This includes writing and maintaining standard operating procedures (SOPs) for the QA department and other departments.
- Preparation, Issuance and Distribution of controlled documents: This includes issuing, stamping, and distributing controlled documents, such as approved procedures, specifications, and protocols.
- Preparing manufacturing records: This includes preparing batch manufacturing records (BMRs) and batch packaging records (BPRs) for production. It also involves Issuance of different Products batches manufacturing records from the master batch records according to the production plan, allocating unique numbers and handing them over to production department.
Qualifications, Skills and Experience:
- Bachelor of Science Technology- chemistry/ BSc. Chemical Engineering / BSc. Industrial chemistry or BSc. Pharmaceutical sciences, Bachelor of Pharmacy or any related course.
- At least 2 years’ experience in QA / QC Operations.
- Experience in pharmaceutical manufacturing environments will be an added advantage
How to Apply:
Submit your CVs to [email protected]
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Level of Education: Bachelor Degree
Work Hours: 8
Experience in Months: 24