Quality Assurance Manager

Job Description

The ideal candidate is a critical thinker who will proactively improve the quality systems of the company through internal audits, participation in process improvement programs, and interaction with key partners to obtain constructive feedback. Key Responsibilities Lead and manage the Quality Assurance team and oversee the implementation of the site’s Quality Management System (QMS) . Ensure GMP compliance across manufacturing, packaging, and warehouse operations. Approve SOPs , BMRs/BPRs , specifications, and ensure adherence to documentation practices. Supervise batch release and review all batch records before product dispatch. Manage quality audits (internal and external) and ensure timely closure of CAPAs . Handle client audits and regulatory inspections (e.g., State FDA, CDSCO) and respond to audit observations effectively. Review and approve change controls , deviations , OOS/OOT investigations , and ensure timely closure with proper root cause analysis. Monitor and drive continuous quality improvement initiatives. Oversee vendor qualification , quality agreements , and ensure compliance of third-party service providers. Collaborate with production, QC, warehouse, and R&D departments to resolve quality issues and improve operational efficiency. Required Qualifications & Skills B.Pharm / M.Pharm / M.Sc in a relevant discipline. Minimum 5 years of experience in a senior QA role within a pharmaceutical formulation manufacturing unit. Prior experience in a contract manufacturing organization (CMO) is strongly preferred. Strong understanding of Schedule M , GMP , ICH guidelines , and quality system requirements. Hands-on experience in handling audits , document control , and batch release . Excellent analytical, leadership, and communication skills. Preferred Skills Exposure to regulatory audits (e.g., WHO-GMP, PICS, etc.) Proficient in Microsoft Office and QMS software tools Strong organizational and time management skills Ability to manage multiple client requirements with high attention to detail