Job Description
Responsibilities
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To execute the planned laboratory activities in compliance with the cGMP and maintaining a safe work environment as per SHE norms.
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To adhere with training schedule, in completion of training requirements and method qualifications.
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To write, review of analytical method validation protocol and reports, planning and execution in compliance to regulatory norms.
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Preparation, execution and review of technology transfer of analytical methodologies.
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Ensure compliance towards quality systems and timely closure of QMS elements in the laboratory with thorough investigations
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To Initiate and close change controls for system improvements and new method/system implementation.
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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.
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To prepare or review of SOP’s, STP’s and ROA’s.
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Support for regulatory inspections and to support and plan for commercial release testing.
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Maintaining instruments along with routine calibration.
Qualifications
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
