Assistant Manager Quality Assurance (OSD)

Role Overview: As an Assistant Manager Quality Assurance at a Global Pharmaceutical MNC based in Mumbai, your role will be crucial in ensuring high-quality standards across product development, manufacturing, and distribution in alignment with company values and regulatory compliance. Key Responsibilities: - Manage and maintain quality systems across manufacturing, development, analytical, and warehousing sites. - Conduct regular audits of CMOs/CDMOs, analytical labs, warehouses, and RM/PM vendors. - Support regulatory audits, handle global quality queries, and ensure compliance with cGMP/GLP and evolving drug regulations. - Prepare and maintain quality-related SOPs and agreements with external partners. - Investigate and manage market complaints, product recalls, and counterfeit product issues. - Oversee the release and global coordination for imported products. - Collaborate with departments like Sales, Legal, Purchase, Finance, Medical, and the global CMC team for quality-related support. - Perform comparative studies of generic products as required. Qualifications Required: - B.Pharm degree with 10+ years of experience in QA within a mid-to-large multinational pharma company. - Qualified auditor. In this role, you will be expected to utilize your strong analytical, planning, and decision-making abilities. Your excellent attention to detail and communication skills will be vital in effectively collaborating as a cross-functional team player.,