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Job description

**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 new 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.