Role :

- Role for Quality Assurance activities which Includes Bulk Manufacturing, HR/Admin and Warehouse area Compliance &
- Handling of QMS elements Pertinent to Entire Bulk Manufacturing, Engineering, HR/Admin and Warehouse area.

- Overseeing day to day activities of Bulk Manufacturing area and ensuring the cGMP compliance.

- Support to Audit and Compliance activities at the site i.e., internal / external audits with their response submission, CAPA actions etc.

Responsibilities

- Preparation &
- Review of SOPs pertinent to QA SOPs Through EDMS
- To Handle Out of Specification (OOS), Deviation, Out of Trend (OOT), Laboratory Event, Change Control, Corrective Action and Preventive Action (CAPA) with assurance of appropriate Action Plan Through TrackWise System.

- To ensure GMP compliance to approved procedures / practices as per SOP.

- Compliance verification in Bulk Manufacturing, Ware house, HR/Admin, Engineering,



QC by visits.

- Review of Protocol &Reports; w.r.t Validation.

Stability

Study, Hold times Studies.

- Control and reconciliation of RCB, Master / Working Cell Banks and maintenance of relevant documentation.

- Review of BPR &

- Batch release, Analytical data Review and Closure.

- Handling of Coordinator role for EDMS.

- Handling of Coordinator role for Track wise.

- Handling of BRMS application with the QA Approver and QA request Approver.

- Handling of QMMR application with preparation / reviewer role.

- Preparation of APQR, data trending by collecting the Process / Analytical data in coordination with Mfg. &

- QC teams.

Preferred candidate profile

Candidates with relevant Experience will be preferred

📌 Sr Executive - Quality Assurance (Bengaluru)
🏢 SUN PHARMA
📍 Bengaluru