Job Description:

Head - Quality Assurance

Department:

Quality Assurance

Reporting To:

Chief Operating Officer / Managing Director

Seeking an experienced Head - Quality Assurance to lead the Quality Assurance function for a reputed pharmaceutical organisation in Pune. The position involves strategic leadership of quality systems, regulatory compliance, manufacturing quality operations, and continuous improvement initiatives. The incumbent will ensure adherence to cGMP standards, maintain product quality, strengthen quality processes, and ensure inspection readiness across manufacturing operations.

Main Roles & Responsibilities:

- Lead and oversee the overall Quality Assurance function across pharmaceutical manufacturing operations.

- Establish, implement, and maintain robust Quality Management Systems (QMS).

- Ensure compliance with cGMP, WHO-GMP, USFDA, EU-GMP, and other applicable regulatory requirements.

- Oversee batch record review, batch release, deviations, CAPA, change control, and investigations.

- Drive internal audits, external audits, regulatory inspections, and compliance readiness.

- Ensure effective management of product complaints, quality deviations, and out-of-specification (OOS) investigations.

- Monitor manufacturing processes to ensure consistent product quality and process compliance.

- Lead risk assessment, quality reviews, and continuous improvement initiatives.

- Collaborate with Production, Quality Control, Regulatory Affairs, Engineering, and Supply Chain teams.

- Develop quality policies, SOPs, and procedures in line with regulatory standards.

- Lead, mentor, and develop the Quality Assurance team.

Required Skills & Competencies:

- Strong expertise in pharmaceutical Quality Assurance and Quality Management Systems.

- In-depth knowledge of cGMP, WHO-GMP, USFDA, and international regulatory guidelines.

- Experience in regulatory audits and inspections.

- Expertise in deviations, CAPA, change control, and risk management.

- Strong leadership, decision-making, and team management capabilities.

- Excellent analytical, communication, and problem-solving skills.

Experience:

- 15 - 20 years of experience in pharmaceutical Quality Assurance.

- Proven experience leading QA operations in pharmaceutical manufacturing.

- Strong exposure to regulatory inspections and quality compliance.

- Experience in managing cross-functional teams and driving quality excellence.

Education:

- B.Pharm / M.Pharm / M.Sc. qualification is preferred.