Deputy Manager

Job Description

Job Description :

1. Preparation, Review & approval of investigation reports, risk assessment, impact assessment reports and other documents as an when required.
2. Handling of product quality complaint (Adverse Event) related to Pharmacovigilance and market complaint investigations in CHEX system as per procedure in co-ordination with Pharmacovigilance team for adverse events as applicable.
3. Handling of ENSUR system for issuance & retrieval of SOPs, specification, ATRs, work sheet & stability protocol management, BMR, BPR, BFR as on when required.
4. Ensure the document control, archival, retention and destruction as defined in the procedure as and when required.
5. Master and obsolete copies management for SOPs, specification, ATRs, work sheet & stability protocol, BMR, BFR, BPR etc.
6. Tracking of SOPs, procedures, specifications etc. for revision as per the validity period.
7. Responsible for archival management i.e. Archival and retrieval of documents as on when required.
8. Review the quality system documents such are protocols, reports, procedures, APQR, trend analysis reports, continual process verification reports etc. as on when required.
9. Sharing the documents to the RA department for filing updation based on change control implementation.
10. Preparation, review of customer, external audits compliance reports etc.
11. Review and approval of analytical reports such are batch analysis, standards, stability study etc.
12. GMP verification and compliance review.

Comply with SHE Guidelines, SHE Rules and Regulations comply with usage of PPE wherever applicable.

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