Senior Executive - QA

Summary Job Functions:

Responsible for document review (Ex. Master MPCR/BPCR, QMS documents, SOP, Protocols &

Reports) related to BBM, MSAT & R&D. Responsible for IPQA activities and Shop Floor

Compliance in BBM Facility. Responsible for transactions required in software related to GMP

activities

Key Responsibilities:

- 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.

- Review of new & revised documents and related transactions in respective software. (SOP,

EBMR, BPCR, MPCR, TTD, PTN, Protocol, Report and QMS documents of BBM, MSAT and R&D).

- Review of Change Controls, CAPA, Deviations, OOT, OOS and related transactions in

respective software.

- 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.

- 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.

- Review of Electronic record and Audit trail related to equipment/systems of BBM Facility.

- 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 respective

software.

- Responsible for EBMR/ E-Logbook Data creation, modification In SAP. Responsible for linking

BOM with the effective MPCR in case of EBMR in SAP.

- Monitoring and participation in Process Validation/Cleaning Validation activities of BBM. Review

and compilation of Process Validation/Cleaning Validation documentation.

- Participation in internal/external audits.

- Preparation and review of the documents related to the quality assurance

- Responsible for providing required document support to RA, R&D and DQA.

- To follow Good Documentation Practices and Data Integrity’ requirements during any GxP

Operation and recording at site.