Manager - QA

As an experienced Quality Assurance professional in the Active Pharmaceutical Ingredient (API) industry, your main responsibility will be to implement and maintain GMP-compliant Quality Management Systems. Your focus will be on ensuring product quality, regulatory compliance, and operational excellence. This role requires expertise in validation, change control, and continuous quality improvement within a highly regulated API manufacturing environment. Your key responsibilities will include managing documentation, handling audits (both regulatory and customer audits), overseeing batch release, conducting deviation investigations, and ensuring adherence to global regulatory standards such as cGMP, ICH, and FDA regulations. You will also be involved in quality planning and scheduling, implementation of QMS, GMP, cGMP, ISO, and Food Safety Standards, compliance with statutory and regulatory requirements, document management and control, review and implementation of quality system procedures and SOPs, batch review, approval, and release, in-process control and material management, review of product stability and test data, handling of OOS, deviations, and batch failures, new product technology transfer, internal, vendor, and customer audit handling, annual product review, GMP and QMS training coordination, validation and calibration program control, quality oversight, and continuous compliance monitoring. To be eligible for this role, you should have a qualification in B Pharma or MSc Chemistry with 10 to 15 years of relevant experience. Your skills should include expertise in GMP, quality assurance, audit handling, quality management systems, change control, food safety standards, documentation management, ISO, API manufacturing, compliance, validation, and cGMP.,