Dr.Reddys Laboratories
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);Â 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;Â 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 :
- 6-8Â 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)Â /M PharmÂ
