Role & responsibilities

The Corporate QA Asst. Manager Veterinary is responsible for ensuring the quality, safety, and regulatory compliance of veterinary pharmaceutical products, biologicals, feed supplements, and thirdparty manufactured products. The role oversees QA systems, audits, validation, documentation, and ensures adherence to GMP, GLP, GCP, and relevant animal health regulations.

Corporate Quality Governance

- Establish and oversee corporate quality policies, systems, and governance frameworks for the veterinary business.

- Harmonize QA processes across thirdparty manufacturing units.

- New product evaluation for veterinary products as per relevant regulatory and pharmacopeial requirements.

Regulatory Compliance & Inspection Management

- Lead corporate readiness for inspections by national and international agencies.

- Act as the global QA representative during audits and resolve highrisk regulatory observations.

Oversight of ThirdParty Manufacturing (TPM) & Suppliers

- Develop corporate qualification, approval, and monitoring systems for contract manufacturers and suppliers.

- Conduct GMP audits and performance reviews of thirdparty sites.

- Ensure robust Quality Agreements, Technical Agreements,



and Risk Assessments for all TPM partners.

Current Product Development & Tech Transfers

- Provide QA oversight for new veterinary product development (pharma, biologicals, feed additives, vaccines).

- Approve technology transfers between R&D;, pilot, and manufacturing sites.

- Ensure quality risk assessments for formulation changes and scale-ups.

Key Skills & Competencies

- Expert knowledge of veterinary drug regulations, vaccine manufacturing practices, biologicals, immunologicals, and feed supplement regulatory frameworks.

- Strong command of Global GMP including Schedule M, WHO-GMP, BIS and OIE standards.

- Excellent analytical skills with deep understanding of sterile/aseptic operations, microbiology, validation, qualification, and quality risk management.

Preferred candidate profile

- M.V.Sc / B.V.Sc preferred; OR M.Pharm/B.Pharm/M.Sc with strong veterinary QA background.

- 1012+ years of experience in QA within veterinary pharmaceuticals or biologicals.

- Minimum 5+ years in a corporate or multi-site QA role.

- Strong experience in thirdparty manufacturing oversight

📌 Corporate QA Assistant Manager Veterinary (Navi Mumbai)
🏢 Alkem Wellness
📍 Navi Mumbai