Quality Assurance Associate

Dr. Reddys Laboratories Limited; Hyderabad; Sur place; INR 1 200 000 - 1 800 000; Plein temps

Résumé du poste

Dr. Reddys Laboratories Limited seeks an experienced QA professional to oversee cell bank operations, ensure GMP-compliant handling of MCB/WCB, and review related protocols and reports. The role includes documentation, audits support, and cross-functional coordination with manufacturing and regulatory teams.

The candidate will monitor storage environments, manage deviations and CAPAs, and ensure timely deposition of reviewed documents to DCQA, supporting biosimilar production readiness.

Qualifications

• Educational qualification: M.sc (Life Science) /M Pharm.
• Minimum work experience: 6-8 years of industrial experience with specific operational experience in Quality Assurance and Manufacturing (Biosimilars).

Responsabilités

• 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.
• Coordinate with manufacturing, QC, and regulatory teams to ensure cell bank readiness for production.
• Manage deviations, CAPAs, and change controls related to cell bank operations.
• Issue Work Cell Banks (WCB) and Master Cell Banks (MCB) as per requiremens.
• Batch Production Record (BPR) Review & Documentation
• Review executed Drug Substance (DS) BPRs and associated documents for all products.
• Ensure timely deposition of reviewed documents to the DCQA.

Formation

M.Sc (Life Science) / M.Pharm

Description du poste

Responsibilities

• 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.
• Coordinate with manufacturing, QC, and regulatory teams to ensure cell bank readiness for production.
• Manage deviations, CAPAs, and change controls related to cell bank operations.
• Issue Work Cell Banks (WCB) and Master Cell Banks (MCB) as per requiremens.
• Batch Production Record (BPR) Review & Documentation
• Review executed Drug Substance (DS) BPRs and associated documents for all products.
• Ensure timely deposition of reviewed documents to the DCQA.

Qualification & Experience

• Educational qualification: M.sc (Life Science) /M Pharm
• Minimum work experience: 6-8 years of industrial experience with specific operational experience in Quality Assurance and Manufacturing (Biosimilars)