Kerja Sepenuh Masa, Assistant Manager-Deputy Manager, Batch Disposition - Release di Biocon Johor - Maukerja

Job Responsibilities:

Batch Release Coordinator / Batch Release Reviewer

1. Tracks batch release status
2. Reviews open deviations, OOS, CAPA, and Change Controls
3. Coordinates with Production, QC, QA, and Validation teams
4. Updates daily tracker after perform release and track the open investigation, interim investigation in Veeva.

QA Batch Record Reviewer

1. Performs GMP review of BMR (SFG/pen assembly)/BPR (Packing record)/DR (dispatch record)
2. Verifies completion of manufacturing and packaging documentation
3. Assesses documentation discrepancies

QA Disposition Approver

1. Evaluates batch impact from deviations and investigations and evaluate SISPQ impacts towards the product prior to the release respective market.
2. Prepare quality statement for the impacted batches (SISPQ impact).
3. Approve the BOM, Block and unblock in the SAP.
4. Prepare Batch disposition checklist, batch approval form, End of user certificate, and Certificate of conformance.
5. Check Market Authorization and new market launch and prepare necessary documents.
6. Approves Release, Reject, Reprocess, or Hold decisions.
7. Update the tracker once release done.
8. Prepare MRM slide and prepare monthly data of the released batches as per TAT.
9. Released full release and getting acknowledged from QP.
10. Request SUQ from SCM and evaluate the batch prior to the market release in accordance.
11. Archive the BMR SFG and Pen Assembly and BPR as per archival procedure in the system.
12. Closure of the deviation, Change action, change control on time.
13. Response the QP queries on time for the requested details.
14. Scan and upload the Europe, Canada Accuristix and US (BPR, BMR, COC, EOU, DR, details of the previous and current version with change control details and etc).
15. Support L1 regulatory and provided requested details pertaining to the US market and EU market.
16. Qualified Person (QP) / Authorized Release Personnel (where applicable)
17. Provides final certification for market release
18. Confirms compliance with regulatory and GMP requirements
19. Approve the BMR(SFG and pen assembly, BPR) during the full release.
20. Scan and upload the Europe, Canada Accuristix and US (BPR, BMR, COC, EOU, DR, details of the previous and current version with change control details and etc).

Qualified Person (QP) / Authorized Release Personnel (where applicable)

1. Provides final certification for market release
2. Confirms compliance with regulatory and GMP requirements
3. Approve the BMR(SFG and pen assembly, BPR) during the full release.
4. Scan and upload the doc in the share points(EU,US and Accuristix).