Description:
Job Title: Head - FDA Products
Company: Our Client (Leading Pharmaceutical Manufacturer)
Location: Gurgaon (WFO)
CTC: 25-40 LPA
Employment Type: Full-time
About the Role:
Our Client is setting up a new pharmaceutical manufacturing facility in Kutch, Gujarat. We are looking for an experienced Head - FDA Products to lead the technical setup, regulatory readiness, and overall operations of the plant.
Key Responsibilities:
- Implement advanced, scalable technologies and ensure strong cGMP compliance.
- Lead process development, scale-up, and validation activities.
- Drive specialty products including oncology, hormones, steroids, and high-value injectables.
- Establish GMP documentation and prepare the site for WHO / USFDA audits.
- Support dossier development and WHO PQ submissions.
- Mentor Production, QA, QC, and Engineering teams.
Qualifications: M.Pharm / B.Pharm / Ph.D. in Pharma Sciences, Chemistry, or related field.
Experience:
- Strong hands-on background in APIs, injectables, formulations, excipients, and biopharmaceuticals.
- Experience in plant setup, validation, scale-up, and regulatory inspections.
- Strong understanding of WHO/USFDA/EU guidelines and technical documentation.
- Proven leadership and ability to drive compliance and operational excellence.
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