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Job Purpose
- To ensure that all finished pharmaceutical products are reviewed, released or rejected in compliance with approved specifications, cGMP standards and regulatory requirements before distribution or sale.
- The role is also responsible for maintaining accurate product and batch statuses on the Oracle system and ensuring that all related manufacturing, packaging and quality documentation is complete and compliant.
Key Job Outputs
- Manage and control the release of all Finished Product batches for sale.
- Performs release of all finished products by verifying compliance of each batch of product with release specifications and regulatory requirements.
- Perform review of the batch manufacturing records (BPR) to ensure compliance with master documentation and specifications prior to release of bulk for packing.
- Verify correct manufacture and expiry dates of products on the Oracle system and record the same on the batch packaging documentation for all products prior to release of bulk product for packaging.
- Perform detailed audit of completed batch manufacturing and packaging records of all manufactured products.
- Ensure that the necessary in-process checks and controls during manufacturing and packaging are correctly recorded in the batch packaging records of batches awaiting release
- Ensure Analytical QC reports are available for each batch of product awaiting release and results are in compliance with registered specifications
- Address and investigate deviations identified during batch documentation reviews and propose CAPA where necessary.
- Release all batches of finished products on the Oracle system as per defined procedure
- Plan and prioritise release of batches within specified time frames to meet MPS requirements.
- Maintain the lot status of all finished products on the Oracle System
- Ensure closure of shop orders on the Oracle system after final product batch releases
- Reviews post importation product samples and analytical reports for compliance with specification and procedures
- Perform release on post importation products in Oracle in accordance with required timelines/priorities.
- Manages the QA Document Auditor to ensure production and packaging queries picked up during batch record review are followed up with production personnel
- Follows up on documentation quality issues raised by the Document Auditor
- Ensures inspection of all finished products is performed by the QA Line Inspectors according to procedure.
- Ensure completed records archived in records room by the Document Administrator
- Escalates any major or critical non-conformities/deviations found during batch records review to the QA Manager and Responsible Pharmacist.
- Compliance to cGMP requirements
- Finished Product Release of all products for distribution/sale
- Maintenance of status of all lots of finished products on the Oracle system
- Achievement of the MPS targets/objectives
- Update/correct manufacture and expiry dates of all bulk product on the Oracle system
- Release or reject finished products
- Change the status of all products on the Oracle system
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