DGM - R&D Quality. GCP QA

Job Description Job Title DGM - R&D Quality. GCP QA Business Unit Global Quality & Compliance Job Grade G8 Location : Baroda 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. Key Responsibilities - Implement GCP requirements as per National & International regulatory guidelines / regulations for conducting BA/BE and Phase-I studies at Pharmacokinetic Department (PKD) through implementation of robust Quality Assurance (QA) program. - Supervise, monitor and execute R&D GCP QA program at Vadodara to ensure compliance as per GxP and regulatory requirements for in-house and outsourced BA/BE (conducted in patients and/or in healthy volunteers) studies. - Plan, supervise, monitor and perform audits like in-process audits, retrospective audits system/facility/process-based audits etc. of in-house and outsourced bio-equivalence studies in order to identify gaps and areas of improvement for compliance to regulatory requirements. Supervise creation of appropriate Corrective Action and Prevention Action (CAPA) plan and its execution to meet necessary compliance standards. - Plan and conduct/ supervise qualification/ requalification audits of Contract Research Organizations (CROs), Contract Service Providers (CSPs)/ Material Suppliers. - Verify adequacy of created & executed Corrective Action and Prevention Action (CAPA) plans. - Support and coordinate regulatory inspections, review of regulatory response and reply to regulatory inspection queries/observations in a time bound manner. Support implementation of appropriate CAPA for the identified gaps. - Monitor, supervise and review SOPs, ATPs, study protocols, instrument qualification, incidents, investigations and change control documents. - Evaluate current systems and processes and create/revise and implement new/revised Standard Operating Procedures (SOPs) and global documents, as required, in collaboration with relevant stakeholders at R&D. Harmonize systems and processes with other GCP sites, as applicable. - Ensure departmental Management Review Meetings (MRMs) are arranged and conducted on time to evaluate quality and compliance status and action items agreed are reviewed periodically. - Issue Quality Assurance Audit Statement/ Certificate as per applicable requirements. - Monitor overall Quality Management System of GxP functions at site. - Create Training Plan for site R&D Quality-GCP QA team. Ensure necessary training is imparted to new joinees and existing staff and assessment of training is conducted in a timely manner. Impart or assist in imparting training and monitor training program for R&D Quality - GCP staff for applicable guidelines, regulations, best practices etc. - Mentor and coach both the direct and, as appropriate, indirect reports through ongoing example-based performance feedback, annual performance reviews and the provision of training and development opportunities. Ensure that performance issues are managed in a consistent and timely manner. - Mentor and coach both the direct and, as appropriate, indirect reports through ongoing example-based performance feedback, annual performance reviews and the provision of training and development opportunities. Ensure that performance issues are managed in a consistent and timely manner. - Develop team expenses, capital budget and head projections. Track and manage expenditure and headcount to budget over the fiscal year. Travel Estimate Job Requirements Educational Qualification M. Pharm / B. Pharm - post graduate degree in basic sciences with at-least 15+ years of experience in GCP environment of which at least 08-10 years experience must be in Quality Assurance. Experience High level of understanding of local and international GCP regulations and clinical research processes including of outsourced studies. Experience of implementing GCP Quality programs and conducting GCP audits. Experience of qualification of CROs/CSPs/ Material suppliers. Experience of qualification of CROs/CSPs/ Material suppliers. Experience of conducting internal and external audits. Experience in handling regulatory agency inspections at sites. Excellent auditing skills. Ability to lead, manage and motivate people with a variety of skill sets. Good knowledge of IT/computer systems. 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).