Role & responsibilities

Responsible for Alkem Wellness limited and Veterinary business for following Activities.

- Manage Corporate Quality Assurance activities for Wellness and Veterinary business operations.
- Conduct audits and ensure compliance of new and existing manufacturing sites.
- Prepare, review, and update SOPs, guidelines, policies, and quality documents.
- Review Quality Agreements for Loan License (LL) and Third-Party (TP) manufacturing sites.
- Perform batch release activities for LL/TP products.
- Evaluate new products and site transfer proposals from a quality and compliance perspective.
- Coordinate and track new product development and technology transfer activities.
- Review and approve first-pack samples, artworks, and packaging materials.
- Review and approve analytical documents, testing procedures, validation reports, and stability data.
- Ensure compliance with pharmacopoeial changes, regulatory requirements, and gazette notifications.
- Handle market complaints, quality queries, investigations, and product recall activities.
- Maintain oversight of Third-Party Manufacturing (TPM) operations and Quality Management Systems (QMS).




- Coordinate with cross-functional teams including Regulatory Affairs, Manufacturing, R&D;, Supply Chain, and Commercial functions.
- Support SAP-related quality activities, including product-site linkage and FG code approval.

Preferred candidate profile

- M.Pharm / B.Pharm / M.Sc. with a strong analytical background.
- 510 years of experience in Quality Assurance, Corporate Quality Assurance, or Quality Compliance within the pharmaceutical industry.
- Hands-on experience in Third-Party Manufacturing (TPM) and Loan License operations.
- Strong knowledge of GMP, QMS, regulatory requirements, audits, investigations, CAPA, and change control.
- Experience in recent product evaluation, technology transfer, product launch, and artwork approval processes.
- Familiarity with analytical documentation, validation, stability studies, and batch release activities.
- Working knowledge of SAP and quality-related workflows.
- Excellent communication, stakeholder management, and problem-solving skills.
- Ability to work independently and effectively manage multiple projects and priorities.

📌 Quality Assurance Officer (Navi Mumbai)
🏢 Alkem Laboratories
📍 Navi Mumbai