Sr Executive - Quality Assurance

Sun Pharma; Bengaluru; On-site; INR 800,000 - 1,300,000; Full time

Job summary

Sun Pharma Bengaluru is seeking a Quality Assurance professional to oversee QA activities across Bulk Manufacturing, HR/Admin and Warehouse, ensuring cGMP compliance and active support for audits and CAPA workflows.

You will handle SOPs, deviations, change controls and validation reviews, coordinating with Mfg/QC teams to ensure timely data trending and batch release support.

Qualifications

• Knowledge of GMP/cGMP practices and QA systems.
• Experience in QA in bulk manufacturing and related QC/Engineering areas.
• Experience supporting internal/external audits and CAPA tracking.
• Proficiency with SOP development and change control processes.
• Familiarity with EDMS/TrackWise/BRMS/QMMR systems.

Responsibilities

• Prepare and review QA SOPs within EDMS.
• Handle OOS, Deviation, OOT, CAPA actions with appropriate plans.
• Ensure GMP compliance with approved procedures and practices.
• Verify compliance across Bulk Manufacturing, Warehouse, HR/Admin, Engineering, QC.
• Review Validation Protocols/Reports; assess stability and hold times.
• Manage documentation: RCB, Master/Working Cell Banks.
• Review BPR & Batch Release, analytical data review and closure.
• Coordinate EDMS, TrackWise, BRMS, QMMR processes with QA.
• Prepare and review APQR and trend data with Mfg/QC teams.

Skills

Quality Assurance

cGMP compliance

Audit & Compliance

SOP preparation

CAPA management

QA documentation

OOS/Deviation/OOT handling

Validation review

Data trending

Cross-functional coordination

Tools

TrackWise

EDMS

BRMS

QMMR

Job description

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