QA Head

Job Description

Head of Quality Assurance (Pharma)Position: Head – Quality Assurance (QA)
Department: Quality Assurance
Reports To: Managing Director / Plant Head / VP – Quality
Location: Nalagrah HP
Role Summary

The Head of Quality Assurance is responsible for leading the QA function to ensure that all pharmaceutical products are manufactured in compliance with cGMP, regulatory guidelines (USFDA, EMA, MHRA, WHO, CDSCO, etc.), and company quality standards. This role oversees quality systems, documentation, audits, training, compliance, and continuous improvement initiatives to maintain a state of inspection readiness at all times.

Key Responsibilities

• Quality Systems & Compliance
• Establish, implement, and monitor Quality Management Systems (QMS) in line with global regulatory requirements.
• Ensure compliance with ICH, WHO, USFDA, EMA, MHRA, CDSCO, and other regulatory guidelines.
• Oversee change control, deviations, CAPA, OOS/OOT, risk management, and product quality reviews.
• Documentation & Records
• Approve SOPs, Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), and quality policies.
• Maintain data integrity and electronic documentation compliance.
• Audits & Inspections
• Prepare the site for regulatory and customer audits/inspections.
• Lead internal audits and vendor audits; ensure timely closure of audit findings.
• Team Leadership & Training
• Lead and mentor the QA team, ensuring continuous training on GMP and quality standards.
• Foster a culture of compliance, integrity, and continuous improvement.
• Product Quality & Release
• Ensure timely review and approval of batch manufacturing and analytical documents.
• Authorize batch disposition/release in compliance with regulatory requirements.
• Cross-functional Collaboration
• Work closely with Production, QC, R&D, Supply Chain, and Regulatory Affairs teams.
• Provide QA support for technology transfer, validation, and new product launches.
• Continuous Improvement & Risk Management
• Drive initiatives for operational excellence and quality improvements.
• Implement Quality by Design (QbD) and risk-based approaches in manufacturing.

Qualifications & Experience

• Education: M. Pharm / B. Pharm / M.Sc. (Chemistry / Biotechnology / Microbiology).
• Experience: Minimum 15+ years in Quality Assurance/Quality Control in the pharmaceutical industry, with at least 5 years in a leadership role.
• Strong knowledge of global regulatory requirements (USFDA, EU, MHRA, WHO, TGA, CDSCO, etc.).
• Proven experience in handling regulatory inspections and audits.
• Excellent leadership, communication, and decision-making skills.

Key Competencies

• Strong understanding of cGMP, GLP, GDP.
• Leadership and people management.
• Analytical thinking and problem-solving.
• Strategic planning and execution.
• Inspection readiness and compliance mindset.

Job Type: Full-time

Pay: ₹80,000.00 - ₹90,000.00 per year

Benefits:

• Food provided
• Health insurance
• Provident Fund

Work Location: In person

Speak with the employer
+91 7657867748