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Description: Responsibilities - To execute the planned laboratory activities in compliance with the cGMP and maintaining a safe work environment as per SHE norms. - To adhere with training schedule, in completion of training requirements and method qualifications. - To write, review of analytical method validation protocol and reports, planning and execution in compliance to regulatory norms. - Preparation, execution and review of technology transfer of analytical methodologies. - Ensure compliance towards quality systems and timely closure of QMS elements in the laboratory with thorough investigations - To Initiate and close change controls for system improvements and new method/system implementation. - To involve in compliance towards Quality Systems and timely initiation and closure of QMS elements (Deviation/OOS/OOT/incident/CAPA) in the laboratory with thorough investigations. - To prepare or review of SOP’s, STP’s and ROA’s. - Support for regulatory inspections and to support and plan for commercial release testing. - Maintaining instruments along with routine calibration. Qualifications Educational qualification: A Bachelor’s in Chemical Engineering or a Master’s in Science Minimum work experience: 6 to 9 years of experience in working with Biosimilar Products