Associate QA - EPD Quality Systems for Leading MNC Pharma Company based at BKC

Job Description:

Primary Job Function:

This position is responsible for managing Quality Systems–related initiatives within the EPD Quality Organization to ensure the supply of safe, effective, and high-quality products in compliance with regulatory and business requirements.

The role also involves managing TPM QA Quality Management System (QMS) activities and related documentation.

Core Job Responsibilities:

Perform assigned Quality System activities to ensure compliance with established quality standards.

Prepare, maintain, and track the following quality documents for Third Party Manufacturers (TPMs) and TPM-related products:

Quality Technical Agreements (QTAs)

Executive review reports prepared after reviewing Product Quality Reports (PQRs), along with regulatory statements

Compliance review and reporting for TPM products in accordance with ICH Q3D guidelines for elemental impurities

Monitor the periodic review of documents as per procedural requirements.

Coordinate and track customer complaints through the TrackWise / SolTRAQ systems, including timely notification to TPM partners and internal stakeholders.

Facilitate the coordination, management, and tracking of complaint samples as required by TPMs.

Identify variation approvals that impact CMC dossier sections for Drug Substance (DS) and Drug Product (DP).

Coordinate with TPMs to ensure alignment of on-site manufacturing and analytical processes with the approved regulatory dossier for each market, supported by reviewed SIR reports.

Act as a Subject Matter Expert (SME) for assigned Quality Systems.

Participate in QA cross-functional team activities as required. 

it will be on role of Talisman HR Solutions Pvt Ltd

If interested, kindly share the details below -

Current CTC

Expected CTC

Notice Period

Reason for Leaving

Updated Resume