KPI is looking for a qualified Quality Assurance Officer to oversee Online Documentation, including preparation, control and daily issuance/ archival of new BMRs and logbooks.

Key Deliverables

1. Document control and record keeping: This includes filing, archiving, and maintaining a robust documentation system for all GMP documents.
2. Writing and maintaining SOPs: This includes writing and maintaining standard operating procedures (SOPs) for the QA department and other departments.
3. Issuing and distributing controlled documents: This includes issuing, stamping, and distributing controlled documents, such as approved procedures, specifications, and protocols.
4. Preparing annual reports: This includes gathering Annual Product Quality Review (APQR) data, graphical presentation and Preparing Annual product review reports and annual training plans.
5. Maintaining master batch records: This includes issuing, updating, and controlling master batch records.
6. 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 handling it to production department.
7. Maintaining Quality Assurance Logs and Databases: This includes updating and maintaining quality assurance operations logs and databases.
8. Participating in audits: This includes participating in internal audits and supporting external audits.
9. Reviewing completed Batching Manufacturing Records: This includes In-process Quality control records and laboratory batch testing records for completeness.
10. Reviewing and analysing logbook data and providing solutions to issues arising from this data
11. Reviewing and maintain integrity of BMR formats and BMR Change processes.

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
• Attention to Detail
• Adaptable