Head – FDA Products

4 days ago


Gurugram, India Antal International, Delhi Full time

Job Title: Head – FDA Products Company: Our Client (Leading Pharmaceutical Manufacturer) Location: Gurgaon (WFO) CTC: ₹25–40 LPA Employment Type: Full-time About Antal Antal International, East Patel Nagar Delhi, is a leading recruitment consultancy having expertise in connecting top talent across IT, Manufacturing and FMCG industries with leading organizations 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 Set up and optimize manufacturing lines for APIs, oral formulations, injectables, and biopharmaceuticals . 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 20–25 years in WHO-GMP pharmaceutical manufacturing. 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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