Manager- Cmo

Job Title Manager CMO - Corporate Quality Business Unit Global Quality Complinace Job Grade G10- Manager-1 Location Mumbai 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 To ensure that SUN Pharma Quality and Compliance Standards and applicable global regulatory authorities requirements are met and that all SUN affiliates CMO Suppliers and SUN sites Operational Units to achieve maintain and improve the adequate level of compliance through Quality Oversight and Independent auditing and Follow-up Key responsibilities Participate in the initial evaluation of Contract Manufacturing Organizations CMOs Oversee and approve Quality Management System QMS elements reported by CMOs including change control deviations incidents Out of Specification OOS Out of Trend OOT results and complaint investigations Review and approve master documents from CMOs such as Batch Manufacturing Records BMR Batch Packaging Records BPR specifications validation protocols and stability protocols Provide support during regulatory audits at CMO sites related to SUN Pharma product approvals Engage in critical investigations at CMO sites including OOS results deviations and complaints Review and maintain quality agreements with CMOs to ensure compliance and quality standards Initiate QMS documents in the Trackwise system inform the respective CMO and track to ensure closure of initiated QMS elements Monitor and oversee activities carried out at CMO sites to ensure compliance with SUN Pharma standards Review executed documents from CMOs related to SUN Product to ensure accuracy and compliance Perform batch release of SUN products manufactured at CMO sites ensuring they meet quality standards Make appropriate transition related to batch releases in SAP system Coordination with the Sun Pharma warehouse for market releases of batches including investigating temperature excursion reports during finished product transport and addressing physical damages reported by the warehouse in finished product consignments Conduct regular visits to CMO sites prepare detailed visit reports and follow up on any issues identified Review and approval of printed packaging artwork Review and approval of formulation orders and packaging orders followed by master recipe approval Involvement as quality oversight during product transfer activities Support for the project management team during the execution of exhibit scale-up batches at the CMO site Preparation and review of the approved vendor list for materials supplied to the CMO site by Sun Pharma Involvement in management notifications batch failure investigations and recall management Support during annual submissions to the Sun Pharma regulatory department Involvement in the preparation of annual schedules annual product reviews and quality agreements To conduct thorough GMP Audit at Vendors manufacturers Raw Materials Excipients and Packaging Materials to SUN Pharma to ensure that they always deliver high quality and standard products and remain compliant with GMP requirements To co-ordinate with Vendor for desired documents for pre-audit preparation logistics resource so as to execute successful audit as per schedule To outline and circulate audit agenda prior to audit The Audit Agenda shall be prepared based on reason behind conducting GMP audit e g Qualification Surveillance or For-Cause Audit To execute on-site audit through facility visit and review of quality management systems established in various functions such as Material Management Production Packing Facility Equipment Quality Systems and Quality Control Laboratory including microbiology lab as applicable To makes sure that SUN Manufacturing Sites Contract Manufacturing Organisations and Affiliate Companies are prepared for Regulatory Agency Inspections e g through Mock inspections audits and supports activities whenever required To ensure during audit that non-compliances to the requirements stated in various guidelines have been identified To communicate the outcome of CMO Audit based on the risk associated with the patient regulatory compliance and business risk to facilitate making decision of Vendor Approval Dis-approval To prepare Planner Schedule Audit Report including non-compliances and review compliance reports thereof to close the audit This includes performing routine follow up of performed audits to ensure timely compliance and closure of the audit To review approved the audit report closure as applicable To maintain evidences and documents related to audit To prepare Monthly report and to highlight the key area of concerns To participate in the trainings to update on current upcoming regulations To follow the Corporate Quality Policies Global Quality Standards GQS and applicable Regulatory Guidelines Participate and execute the project work as allotted by reporting authority To perform the risk assessment Travel Estimate Job Requirements Educational Qualification B Pharm M Pharm Experience Tenure 13 years of experience in Quality Management Systems QMS regulatory audits In-process Quality Assurance audit readiness and remediation activities for the US and other markets 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