13 Aug
|
Pharma Placements
|
Bharuch
13 Aug
Pharma Placements
Bharuch
Job Description Site Quality Head (VP Quality)
Location: Dahej (Gujarat)
Plant Profile : A large-scale OSD Formulation Manufacturing Plant manufacturing Tablets, Capsules, and Oral Suspensions. The Plant is a *US FDA and WHO* Approved Plant
Reporting To: President Corporate Quality Assurance (CQA)
Role Summary:
The Site Quality Head will be responsible for leading the overall Quality function of a high-volume pharmaceutical manufacturing site. The incumbent will ensure compliance with cGMP, regulatory requirements, and global quality standards while driving a solid quality culture across the organization.
Key Responsibilities
- Lead the Quality Assurance and Quality Control functions for the manufacturing site.
- Ensure compliance with cGMP, WHO-GMP, USFDA, MHRA, EU-GMP, and other applicable regulatory requirements.
- Develop and implement site quality strategies aligned with corporate quality objectives.
- Oversee batch release, investigations, deviations, OOS/OOT, CAPA, change control, and risk management.
- Ensure audit readiness for regulatory, customer, and internal audits.
- Drive continuous quality improvement initiatives and quality metrics.
- Collaborate with Manufacturing, Engineering, Supply Chain, Regulatory Affairs, and Corporate Quality teams.
- Lead inspection management and regulatory responses.
- Develop and mentor the quality leadership team while fostering a culture of compliance and operational excellence.
Team Size
- More than 500 professionals
- Plant Strength: Total Workforce: More Than 2,000
Candidate Profile
- Master’s degree in Pharmacy, Chemistry, or a related Life Sciences discipline.
- 18–25 years of experience in pharmaceutical quality, with significant exposure to OSD manufacturing. *The candidate must have worked in a US FDA approved plant of a reputed Pharma Comapnay.*
- Proven leadership experience in heading Quality functions at a large formulation manufacturing facility.
- *Only thosecandidates who are currently working a
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