Site Head/General Manager

3 weeks ago

Andhra Pradesh, India Utkarsh Placement Pvt Ltd Full time

Job Purpose:

To lead and manage the Quality Assurance function at the manufacturing site, ensuring compliance with cGMP, regulatory requirements, and internal quality standards for oral liquids and tablet formulations. The role demands strategic oversight of all QA activities, regulatory inspections, documentation, and continuous improvement to support product quality for regulated markets like USFDA, MHRA, EU, TGA, etc.

Key Responsibilities:

1. Quality Systems Management:

- Ensure robust implementation and maintenance of QMS (Quality Management Systems) in line with ICH, USFDA, EU, and other global regulatory requirements.

- Oversight of deviations, CAPAs, change controls, and risk assessments.

- Review and approval of site-specific SOPs, master documents, validation protocols, and reports.

2. Regulatory Compliance:

- Ensure readiness for and manage regulatory and customer audits (e.g., USFDA, MHRA, ANVISA, WHO, TGA).

- Lead audit preparation, execution, response, and follow-up activities.

- Maintain compliance with data integrity and electronic documentation practices (21 CFR Part 11).

3. Leadership & Team Management:

- Lead and mentor the QA team, fostering a culture of compliance and continuous improvement.

- Develop training plans and oversee periodic training of QA and cross-functional teams.

4. Documentation & Records:

- Final QA approval for BMRs/BPRs, batch release documentation, and CoAs.

- Oversight of document control, archival, and retrieval in compliance with regulatory requirements.

5. Product Quality & Market Support:

- Oversee product quality reviews (APQR/PQR).

- Evaluate and support investigation of customer complaints and product recalls, if any.

- Work closely with QC, Production, and Regulatory Affairs to ensure quality alignment across functions.

6. Validation & Qualification:

- QA oversight of equipment qualification, process validation, cleaning validation, and analytical method validation.

Key Requirements:

- Education: B.Pharm / M.Pharm / M.Sc. in a relevant discipline.

- Experience: Minimum 16 years in pharmaceutical QA, with significant leadership experience in regulated markets.

- Proven experience in handling regulatory inspections (USFDA, EU, etc.).

- Strong knowledge of cGMP, ICH Q-series guidelines, and data integrity principles.

- Exposure to both oral liquids and solid dosage forms is a must.

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