Job Description

We are looking for a Assistant Manager – Quality Assurance for a Global Pharmaceutical MNC based in Mumbai. Position Title: Assistant Manager – Quality Assurance (HO based position) Qualification: B Pharmacy Reporting To: Director – Manufacturing & Product Development Years of experience: 10+ years in QA within a mid-to-large multinational pharma company in OSD Location: BKC, Mumbai Traveling: Travel to company-owned, third-party-operated plants for audits Working structure: 5-day week; may extend to 6 during plant visits Key Objective: Ensure high-quality standards across product development, manufacturing, and distribution in line with company values and regulatory compliance. Core Responsibilities: 1. Quality System & Audits 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, global quality queries, and ensure compliance with cGMP/GLP and evolving drug regulations. 2. Documentation Prepare and maintain quality-related SOPs and agreements with external partners. 3. Complaint & Recall Handling Investigate and manage market complaints, product recalls, and counterfeit product issues. 4. Imported Products Oversee the release and global coordination for imported products. 5. Cross-functional Collaboration Work closely 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. General Duties: Undertake tasks as directed by management, maintaining the highest professional standards. Candidate Profile: Education & Experience: B.Pharm with 10+ years in QA within a mid-to-large multinational pharma company. Qualified auditor. Key Skills: Strong analytical, planning, and decision-making abilities. Excellent attention to detail and communication skills. Effective collaborator and cross-functional team player. Relevant candidates can reach out to me at pooja.j@domniclewis.com Show more Show less