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 current 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 robust 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 current 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 Maharashtra
🏢 Alkem Laboratories
📍 Maharashtra