Quality Assurance Associate

Designation : Associate

Function : Quality Assurance

Functional Area : DS-QA

Job Role Summary : Verify compliance for activities, reviewing real-time investigations, ensuring smooth batch manufacturing and testing activities, and evaluating practices against defined standards

Job Profile

• Drug Substance Quality Assurance (DS-QA); Cell Bank Assurance
• Oversee the qualification, documentation, and traceability of Master and Working Cell Banks (MCB/WCB).
• Ensure compliance with GMP, EU Annex 1, and ICH guidelines for cell bank handling, storage, and distribution.
• Review and approve cell bank-related protocols, COAs, and characterization reports.
• Monitor environmental conditions and alarm systems for cell bank storage units (LN2 tanks, freezers).
• Support audits and regulatory inspections by providing cell bank documentation and responses.
• Manage deviations, CAPAs, and change controls related to cell bank operations.
• Issue Work Cell Banks (WCB) and Master Cell Banks (MCB) as per requirements.
• Batch Production Record (BPR) Review & Documentation
• Review executed Drug Substance (DS) BPRs and associated documents for all products.
• Review and approve Master Formula Records (MFRs), BPRs, Bill of Materials (BOMs), Standard
• Initiate, review, and approve investigations, discrepancies, Corrective and Preventive Actions (CAPAs), Change Controls, and Quality Risk Management (QRM) activities.
• Monitor shop floor activities to ensure compliance with Good Manufacturing Practices (GMP).
• Conduct routine and non-routine spot checks.
• Line Clearance & Critical Activity Oversight; Provide line clearance for product changeovers and oversee critical activities as per SOPs across DS facilities.
• Review and approve process and cleaning qualification/validation protocols and reports. Audit Trail Review
• Review system and process audit trails as per the defined schedule.

Job Requirements

• 6-8 years of industrial experience with specific operational experience in Quality Assurance and Manufacturing (Biosimilars)
• A solid understanding of Quality Systems and the ability to comprehend and navigate counter functions within the organization.
• In-depth knowledge and comprehension of the Bio Pharma and Pharma markets, including product knowledge, market trends, competitors, and customer needs.
• Understanding and familiarity with global cGMP (Current GMP) regulatory requirements, including those set by FDA (U.S. Food and Drug Administration), EU (European Union), and Indian regulatory authorities.

Work / Job Experience : 6-8 Years

Type of Experience : QA, Manufactuing Experience in Biosimilars

Academic Qualifications

• M.sc (Life Science) /M Pharm

Job Post Link : https://tinyurl.com/25e96658

• Full Time
• India | Telengana | Hyderabad
• Posted 3 hours ago

Website Linkedin Dr.Reddys Laboratories To apply for this job please visit careers.drreddys.com.