Head - Fda Products

2 days ago


Faridabad, India Antal International, Delhi Full time

Job Title: Head – FDA ProductsCompany: Our Client (Leading Pharmaceutical Manufacturer)Location: Gurgaon (WFO)CTC: ₹25–40 LPAEmployment Type: Full-timeAbout AntalAntal International, East Patel Nagar Delhi, is a leading recruitment consultancy having expertise in connecting top talent across IT, Manufacturing and FMCG industries with leading organizationsAbout the RoleOur 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 ResponsibilitiesSet 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.QualificationsM.Pharm / B.Pharm / Ph.D. in Pharma Sciences, Chemistry, or related field.Experience20–25 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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