Cluster Support

Job Title Cluster Office- Global Quality Operations Business Unit Global Quality Compliance Job Grade G10 Manager-1 Location Halol 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 Job Summary Provide guidance and support to Site Quality on closing non-compliances lead enhancement projects related to product quality compliance and simplification set milestones for effective execution of project actions maintain substantial compliance at all sites by harmonizing and implementing Quality Systems and procedures in alignment with Global Policies and Standards act as a champion for building a Culture of Quality across the organization and assure that all sites are ready for all Regulatory and Customer inspections at all times Key responsibilities Act as COE to provide guidance to Sites to ensure achievement of target for Quality Compliance as per Management s expectation Review site investigation reports for major critical non-conformances and share comments with site for improvement of root cause analysis Support site for audit readiness by performing gap assessment through site visits and or document review remotely for compliance enhancement and to track the action plan for remediation of gaps identified during Visit Review Support Quality Cluster Head in ensuring Quality or regulatory non-compliance issues don t happen which could lead to product stock-out or withdrawal product approval delays or which would negatively impact the quality financial performance and reputation of the company Common knowledge of regulatory guidelines of USFDA MHRA EU ANVISA WHO Schedule M etc and familiarity with GMP requirements of various regulatory bodies - USFDA MHRA HPRA ANVISA TGA WHO PMDA CDSCO Collaborate with other Cluster Site Quality SGO Heads Supply Chain Business Development R D IT and RA for any specific requirement related to site Quality Track and monitor site performance for improving quality index Identify the key challenges and improvement areas Discussion with site on action plan for improvement Review of batch rejection market complaint FAR Recalls Invalidated OOS - Monthly tracking review and collation of details and discussion with site Quality for action plan Track and monitor Productivity SLA TAT from each site Document productivity trends Manpower analysis pending RM PM NMT 30 day for release and report insights to Cluster Quality Heads Support the development of central strategy to respond to system level audit observations inspection findings and implement corrective actions across sites Support for timely implementation of Quality owned harmonized IT solutions according to plan Regularly update on status of Regulatory inspection CQA audit and upcoming inspection Coordinate with site for annual revenue and capex budget proposal including new headcount proposal Work with Cluster Head to review and submit final proposal to corporate functions Finance HR MDO with Identify and review Quality cost reduction initiatives as per management requirements Review discuss and track projects initiatives tasks Cluster Corporate for completion and closure Work closely with Cluster Quality Head for reviews identifying actionable points and ensuring closures Travel Estimate Job Requirements Educational Qualification B Pharm M Pharm Experience Experience 14 to 15 Yrs in a pharmaceutical organization with good exposure of Quality and Manufacturing Operations A strong knowledge of GMP s in both domestic and international regulatory environments Strong communication skills and goal oriented Excellent negotiation skills relational skills and ability to communicate effectively with all levels of the organization and external stakeholders 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