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 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.
Job Title
Head – FDA Products