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Steersman Talent Acquisition
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Head FDA Products

Head FDA Products

Steersman Talent Acquisition

20 - 25 years

25 - 40 Lacs

gurugram

Posted:-1 days ago| Platform:

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Skills Required

pharmaceutical manufacturing api manufacturing oral formulations who-gmp standards quality compliance cgmp compliance fda compliance hormones & steroids manufacturing specialty pharma biopharmaceutics equipment validation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Title: Head FDA Products

Company:

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.
Role & responsibilities

Preferred candidate profile

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