Executive - R&D Quality

4 days ago

Tandalja, India SUN PHARMA Full time

Title: Executive - R&D Quality Business Unit: R&D Quality Job Grade G12A Location: Vadodara Key Responsibilities At Sun Pharma, we commit to helping you “Create your own sunshine ”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Position Summary – List of Responsibilities: To Review and approve of Analytical method validation protocols , reports, Analytical method transfer protocol/reports, Plant Trouble Shooting Report, Various kind of Analytical technical report , Justification report, etc. To review and approve of QMS documents like change control, deviation, Action items, Investigations, CAPA for cGxP compliance and centralised QA oversight for Analytical Development Department and Microbiology. To review relevant raw data and report for traceability and adequacy to ensure that Method Validation / Method verification/ Method Transfer data verify scientific rigor, adequacy and completeness and to approve relevant reports. To assist in developing procedures / system and for assuring compliance to them by the R&D function by identifying GAP through document review and Audits. To review and approve Extractables and Leachable (E&L) reports. Verify the Product Development Data for the raw data adequacy. To review of Bio Batch/DQ Batch Raw data and release COA in LIMS. To review and approve Analytical development and Microbiology Department SOPs. To effective/Obsolete SOPs and related forms of Analytical Development and Microbiology Department in EDMS. Responsible to approve In-vitro bio study and to ensure compliance as per regulatory requirements/ guidance and established procedure. To perform any other activity assigned by reporting manager. Travel Estimate Low Job Requirements Educational Qualification M.Sc / M. Pharma Experience 5-8+ years Your Success Matters to Us At Sun Pharma, your success and well-being are our top priorities We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together Disclaimer:  The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

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