- Lead the Quality Assurance function for the Paithan manufacturing facility.
- Ensure compliance with USFDA, WHO-GMP, EU-GMP, MHRA and other applicable regulatory requirements.
- Establish and maintain effective Quality Management Systems (QMS).
- Oversee deviations, CAPA, change control, OOS/OOT, investigations and risk management.
- Ensure timely review and approval of BMR/BPR, SOPs, specifications and other quality documents.
- Lead internal audits, vendor audits and regulatory inspections.
- Drive inspection readiness and ensure effective management of regulatory observations and commitments.
- Ensure compliance with Data Integrity and ALCOA+ principles.
- Collaborate with Production, QC, Engineering, R&D;, Regulatory Affairs and Supply Chain teams.
- Monitor quality metrics and identify opportunities for continuous improvement.
- Develop and mentor the QA team and build a strong quality-driven culture.
- Ensure timely closure of quality events and implementation of sustainable CAPA.
- Support new product introduction, process validation, cleaning validation and technology-transfer activities.
- Provide strategic inputs to Plant Management and Corporate Quality on quality-related matters.
Candidate Profile
- Qualification: M.Pharm / B.Pharm / M.Sc. in a relevant discipline.
- Experience: 1520+ years of relevant experience in Quality Assurance within the pharmaceutical manufacturing industry.
- Robust experience in regulated markets, particularly US and other international markets.
- Proven experience in handling USFDA and other regulatory inspections.
- Strong knowledge of cGMP, ICH guidelines, QMS and regulatory compliance.
- Experience in leading large QA teams in a formulation/manufacturing plant.
- Strong leadership, analytical, investigation and decision-making skills.
- Excellent stakeholder management and communication skills.
Key Competencies
Regulatory Compliance | Quality Systems | USFDA Inspection Management | QMS | Data Integrity | Deviation & CAPA | Change Control | Risk Management | Audit Management | Team Leadership | Continuous Improvement