Head – FDA Products

6 days ago

Gurugram Haryana India, IN 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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