01 Oct
|
Inventia Healthcare
|
Ambernath
01 Oct
Inventia Healthcare
Ambernath
- To co-ordinate with BSR, Production and QC with respect to necessary documentation for batch release.
- Review of executed BMR, BPR.
- To review certificate of analysis, In-process analytical data, Process Analytical Data, Process Validation documents, Annual Product Review documents.
- Approval of issuance BMR and BPR through Document Management System.
- To handle QCS inspection for Nigeria Products to get CIRA Report (Clean Report of Inspection and Analysis).
- Retention sample periodic review and destruction.
- Sample management for Regulatory dept., Marketing department. and Clients as per requirement.
- To provide reports to client and revert on queries.
- To ensure compliance of batch related documents and provide to regulatory department for submission.
- MES related activities-electronic batch record-preparation, review, and release activity.
📌 Assistant Manager - Review Team ( BMR and BPR Review ) (Ambernath)
🏢 Inventia Healthcare
📍 Ambernath