Quality Assurance Associate - Drug Substance

Job Summary

We are seeking an individual to verify compliance for activities in the respective counter function regularly. This role involves reviewing real-time investigations, ensuring smooth batch manufacturing and testing activities, and evaluating practices against defined standards, to ensure consistent product quality and operational compliance within the regulatory framework and global standards.

Key Responsibilities – 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.

• 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 requirements.

• 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.

• Document Review & Approval

  • Review and approve Master Formula Records (MFRs), BPRs, Bill of Materials (BOMs), Standard Operating Procedures (SOPs), Product Quality Reviews (PQRs), action plans, and other relevant documents for both existing and new products.

• Protocol & Report Evaluation

  • Review and approve various protocols and reports, including technology transfer documents related to DS manufacturing processes.

• Quality Systems Oversight

  • Initiate, review, and approve investigations, discrepancies, Corrective and Preventive Actions (CAPAs), Change Controls, and Quality Risk Management (QRM) activities.

• Audit Support

  • Provide support during internal and external audits.
  • Ensure timely closure of audit observations and implementation of corrective actions.

• GMP Compliance Monitoring

  • 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.

• SOP & Document Management

  • Create, revise, and review SOPs, forms, and other DS-QA-related documents as required.

• GMP Record Verification

  • Perform periodic verification of GMP records in alignment with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available).

• Qualification & Validation Review

  • 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.
  • Perform audit trail reviews for equipment.

• Issuance of Cell Banks for Manufacturing Operation

• Issue Working and Master Cell Banks to Manufacturing as per approved guidelines, ensuring traceability and compliance.

Educational qualification: M.sc (Life Science) /M Pharm

Minimum work experience: 4-8 years of industrial experience with specific operational experience in Quality Assurance and Manufacturing (Biosimilars)

Skills & attributes:

Technical Skills
• 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.
• Awareness of broader market dynamics, industry trends, and factors influencing the pharmaceutical market.
• Comprehensive knowledge of the specific products associated with the pharmaceutical organization, including their characteristics, manufacturing processes, and quality requirements.
• Ability to understand and implement organizational policies and ensuring compliance.

Behavioural skills
• Demonstrates a commitment to continuous learning.
• Strong communicating and influencing skills.
• Displays analytical and logical thinking abilities.
• Self-motivated and takes initiative.
• Adaptability to the work environment, along with being a team player.
• Ability to go beyond boundaries, showcasing a proactive and innovative approach.

Shift Flexibility

• Demonstrate the ability and willingness to work in rotational shifts, including night shifts, weekends, and holidays, as per operational requirements to ensure continuous QA oversight and compliance.

About the Department : Biologics

Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10–15-year time horizon...

" Benefits Offered

At Dr. Reddy’s, we actively help to catalyze your career growth and professional development through personalized learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards...

" Our Work Culture

Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions...

For more details, please visit our career website at https://careers.drreddys.com/#!/

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