Assistant Manager - IPQA(DS)

Summary Job Functions:

Responsible for overall Monitoring and Compliance of documentation and IPQA activities of DS Manufacturing related to Manufacturing(BBM) facility. Responsible for various document review and approval related to CI & DS.

Key Responsibilities:

- Review, monitoring and follow up for timely completion of Change Controls, CAPA, Deviations, OOT, OOS, IQA/external audit observations related to BBM.

- Review of new & revised documents i.e. SOP, BPCR, MPCR, PTD, TTD, Validation Protocol, Report and QRM related to BBM and MSAT facility.

- Review and to ensure timely completion of BPCR of products (CI and DS) manufacturing in BBM for release. Authorized for batch release of Critical Intermediates, Drug substance and associated in-house media, buffer and column BPCRs.

- Review of electronic data/audit trail data related to Manufacturing(BBM) facility.

- Preparation and Review of APQR related to CI and DS.

- Responsible for Handling and review/assessment of FMS Alarm, Equipment Breakdown, SAP Incident and ERN (Error Ratification Notification) Handling.

- Monitoring and participation in process and cleaning validation activities of BBM. Review/Approval and compilation of Process and cleaning validation documentation/CPV documentation.

- Responsible for In-process Quality Assurance activities (e.g. Area clearance, Issuance of MCB/WCB/EPCB Vial/CI/DS for batch processing, Verification of process steps as applicable) and review of various processing parameters and its associated documentation related to BBM facility.

- Development of technical competency related to CI and DS process

- To carry out the audits (like self-inspection (IQA) or external audits as and when required). Participation in internal/external audits as and when required. Follow-up and closure of Audit observations related to BBM & BBMQA section

- Document preparations related to QA and BBMQA as and when required.

- Responsible for Document number creation, Document number modification, Document upload, Authorize, release and obsolete in SAP, whenever required. Responsible for verification of BOM in SAP. Responsible for doing transactions related to BPCR review and Interim batch release in SAP.

- Responsible for QMS notification creation in SAP, whenever required. Responsible for eBMR/eLogbook Data creation, modification In SAP. Responsible for linking BOM with the effective MPCR in case of eBMRs in SAP.

- Responsible for approval of material request from various user departments related to BBM facility. Responsible for approval/authorization of user access request related to BBM facility.

- Responsible for Approval of documents related to BBM as and when required. like MPCR, BPCR, SOP, Protocol, Report.