Greetings!!!!

Job Description Head Quality Assurance (QA Head)
Experience: 25 - 30 Years (Senior Leadership Profile)
Location: Chennai
Industry: Pharmaceutical API Manufacturing
Role Type: Confidential Leadership Position

Position Overview:

We are looking for an experienced Head Quality Assurance to lead the Quality Assurance function for a pharmaceutical API manufacturing facility. The ideal candidate should have extensive experience in establishing and maintaining robust quality systems, regulatory compliance, and ensuring adherence to global pharmaceutical standards.

Key Responsibilities:

- Lead and oversee the complete Quality Assurance function including Quality Systems, Compliance, Documentation, Validation, and Regulatory activities.
- Ensure compliance with cGMP, USFDA, EU GMP, WHO GMP, and other global regulatory guidelines.
- Develop and implement quality strategies aligned with business and regulatory requirements.
- Provide leadership for QMS, deviations, CAPA, change controls, investigations, and risk management activities.
- Ensure inspection readiness and successfully manage USFDA, EU GMP, MHRA, WHO, and customer audits.
- Review and approve SOPs, protocols, validation documents, quality agreements, and regulatory submissions.
- Drive continuous improvement initiatives to strengthen quality culture across the organization.
- Oversee process validation, cleaning validation, analytical validation,



and qualification activities.
- Ensure effective handling of product complaints, recalls, market complaints, and regulatory commitments.
- Lead, mentor, and develop QA teams to achieve operational excellence.
- Collaborate with QC, Production, R&D;, Regulatory Affairs, and Supply Chain teams for compliance and quality enhancement.

Desired Candidate Profile:

- Ph.D. in Pharmaceutical Sciences / Chemistry / Life Sciences will be an added advantage.
- 2530 years of experience in Quality Assurance within API pharmaceutical manufacturing.
- Extensive experience in handling QA leadership roles in API plants.
- Robust knowledge of global regulatory requirements and quality systems.
- Proven track record in managing regulatory inspections and customer audits.
- Strong expertise in:
- cGMP Compliance
- Quality Management Systems (QMS)
- Regulatory Audits
- Process & Cleaning Validation
- Data Integrity (ALCOA+)
- Deviations, CAPA & Change Controls
- Risk Management

- Excellent leadership, communication, and stakeholder management skills.
- Tamil speaking is mandatory.
- Candidates with experience in Tamil Nadu API manufacturing facilities will be preferred.

Note: This is a confidential leadership position. Company details will be shared only with shortlisted candidates.

Interested Candidates Kindly share your updated cv to [email protected]

📌 Head Quality Assurance_API_Chennai (Chennai)
🏢 BVR People Consulting
📍 Chennai