Group Lead DPQA

To lead Drug Product Quality Assurance activities and provide strategic quality oversight for aseptic manufacturing operations ensuring commercial and clinical drug product batches are manufactured reviewed and released in compliance with cGMP global regulatory requirements and internal quality standards. The incumbent shall be responsible for maintaining a state of control over manufacturing processes sterility assurance programs contamination control strategies data integrity inspection readiness and quality systems while driving continuous improvement and fostering a strong quality culture across the organization.

Key Responsibilities

1. Manufacturing Quality Assurance

• Provide QA oversight for Drug Product manufacturing operations including aseptic processing filling visual inspection and packaging activities.
• Ensure compliance with cGMP GDP Data Integrity (ALCOA) and regulatory requirements on the manufacturing shop floor.
• Review and approve batch manufacturing records and support timely batch disposition and release.
• Act as authorized QA representative for product disposition decisions.
• Drive real-time quality oversight and escalation of critical compliance issues.

2. Batch Release & Product Disposition

• Ensure all quality and GMP requirements are fulfilled prior to batch release.
• Review deviations investigations CAPAs change controls and impact assessments associated with product batches.
• Support risk-based decision-making for batch release rejection reprocessing or rework.
• Review and approve market complaint investigations recalls and mock recall reports.

3. Validation & Qualification Oversight

• Provide quality oversight for:
  • Process Validation
  • Cleaning Validation
  • Aseptic Process Simulation (Media Fills)
  • Equipment Qualification
  • Hold Time Studies
  • Continued Process Verification (CPV)
• Ensure validated state is maintained throughout the product lifecycle.
• Review and approve validation protocols reports and associated risk assessments.

4. Quality Systems Management

• Lead timely closure of:
  • Deviations
  • Investigations
  • CAPAs
  • Change Controls
  • Quality Risk Assessments (QRM)
• Review and approve SOPs protocols reports product quality reviews and GMP documentation.
• Ensure effectiveness verification of CAPAs and continuous improvement initiatives.

5. Sterility Assurance & Contamination Control

• Lead implementation and continuous improvement of the Contamination Control Strategy (CCS).
• Monitor aseptic practices environmental monitoring trends utilities and cleanroom compliance.
• Ensure compliance with Annex 1 FDA EMA WHO and other applicable regulatory expectations for sterile manufacturing.
• Support investigations related to microbial contamination environmental excursions and objectionable organism recoveries.
• Provide oversight for sterility assurance programs and contamination prevention activities.

6. Regulatory Compliance & Inspection Readiness

• Maintain a constant state of inspection readiness.
• Lead and support regulatory inspections customer audits due diligence audits and self-inspections.
• Review audit observations and ensure timely implementation of remediation activities.
• Support preparation of regulatory submissions and health authority responses.
• Drive proactive compliance monitoring and risk mitigation across DP manufacturing operations.

7. Product Quality Review

• Lead preparation review and approval of Annual Product Quality Reviews (APQR/PQR).
• Ensure timely collection analysis and trending of quality metrics.
• Present quality trends compliance risks and improvement opportunities to site leadership.

8. Vendor & External Manufacturing Oversight

• Support supplier qualification contractor qualification and quality agreement management.
• Review quality aspects of outsourced manufacturing testing and service activities.
• Participate in supplier audits and ongoing performance monitoring.

9. Leadership & People Development

• Lead mentor and develop the DPQA team.
• Build a culture of quality accountability compliance and continuous improvement.
• Drive cross-functional collaboration with Manufacturing QC MSAT Engineering Validation and Regulatory Affairs.
• Support succession planning and capability development within the QA organization.

Educational Qualification

• / / . (Microbiology Biotechnology Biochemistry Life Sciences) or equivalent.
• Advanced qualification or certification in Quality Assurance Regulatory Affairs or Pharmaceutical Management is preferred.

Experience

• 15-20 years of experience in Biopharmaceutical Sterile Injectable Vaccine or Aseptic Manufacturing environments.
• Minimum 5 years of leadership experience in Drug Product Quality Assurance or Manufacturing Quality Assurance.
• Hands-on experience supporting global regulatory inspections including USFDA EMA MHRA ANVISA PMDA Health Canada or equivalent agencies.
• Strong experience in aseptic processing contamination control strategy sterility assurance validation and batch disposition.

Technical Competencies

• cGMP and Global Regulatory Requirements
• Data Integrity and Quality Systems
• Aseptic Processing and Annex 1 Compliance
• Sterility Assurance Programs
• Contamination Control Strategy (CCS)
• Process and Cleaning Validation
• Deviation CAPA Change Control and QRM
• Product Quality Review (APQR/PQR)
• Regulatory Inspection Management
• Root Cause Investigation and Risk Assessment

Leadership Competencies

• Strong quality and compliance mindset
• Strategic thinking and business acumen
• Critical decision-making and risk-based judgment
• Team leadership and people development
• Cross-functional collaboration
• Stakeholder management and influencing skills
• Effective communication and coaching capabilities
• Strong drive for inspection readiness and operational excellence

Qualifications :

Educational Qualification

• / / . (Microbiology Biotechnology Biochemistry Life Sciences) or equivalent.
• Advanced qualification or certification in Quality Assurance Regulatory Affairs or Pharmaceutical Management is preferred.

Additional Information :

Our Work Culture

Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were always attuned to the new and the next to empower people to stay fit. And to do this we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic.

Equal Opportunity Employer 

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion age sex sexual orientation gender identity national origin or protected veteran status and will not be discriminated against based on disability. 

For more details please visit our career website at Work :

No

Employment Type :

Full-time