QA Sterile Manager

You will be joining Sun Pharmaceutical Industries Ltd as a QA Sterile Manager in the Quality Assurance department. Your role will involve managing the Quality Assurance functions of the Manufacturing Block P. As the Manager-I, you are required to hold an M.Sc. degree in Biotechnology, Microbiology, or Chemistry with over 10 years of experience in the field. Your responsibilities will include ensuring that manufacturing and packing processes are carried out per SOPs and cGMP regulations. You will be responsible for certifying batch production records, releasing/rejecting batches after thorough reviews, and tracking the QMS system. It will be your duty to investigate complaints, deviations, OOS, and stability failures, ensuring timely closure and contamination controls as per the contamination controls strategy. You will collaborate with various departments like planning, QC, Regulatory Affairs, Manufacturing, and Engineering to ensure batches are released on time. Your role will involve participating in self-audits, aseptic simulations, and identifying opportunities for continuous improvement in compliance, process clarity, and operational efficiency. Reviewing and approving various documents such as master batch production records, protocols, reports, and stability sample management will also be part of your responsibilities. Additionally, you will manage activities related to IPQA, line clearance, in-process checks, calibration records, artwork approval, and provide training to support staff. Your focus will be on enhancing knowledge of cGMPs, improving practices, complying with the Quality Policy, and enhancing systems and procedures to ensure the quality of products manufactured and delivered meets the required standards.,