3 Days Left Cmo Quality Audit Lead

Job Title CMO Audit Lead Business Unit Global Quality Compliance Job Grade G7 General Manager 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 plan and execute quality audits of Global CMO CWH CNF Aseptic consumable suppliers as per the audit program Routine Qualification For Cause audits to ensure maintenance of Quality Standards in compliance to cGMP and regulatory requirements Key Responsibilities To prepare and approve the audit schedule of CMO s CWH CNF s Aseptic consumable suppliers To plan co-ordinate with commercial department to conduct audits as per schedule 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 assign the audits based on the expertise and evaluation of auditor To participate in the audits and to identify non-conformance with respect to Quality Systems Procedures Operations against the regulatory requirements To execute on-site virtual desk audits and review of quality management systems established in all the six systems as applicable To review and approve the audit reports and ensure corrections if any To provide the final audit report to the Commercial Department within 30 calendar days To review and verify the audit responses received from the sites and ensure closure of audit To prepare monthly report and to highlight key areas of concern in the monthly report To participate in the product release sites Qualified Person sites audits to ensure that the product is being released as per the regulatory requirement To communicate the outcome of audit based on the risk associated with the patient regulatory compliance and business risk to facilitate making decision of Approval Di-approval To ensure training of auditors to update on current upcoming regulations To follow Corporate Quality Policies Global Quality Standards and applicable regulatory guidelines To execute Global due-diligence For cause and QMS audits as per the requirement Participate execute the project work assigned by reporting authority To control and monitor the budget expenses of the team Periodic monitoring of annual KPI s of team All other duties as assigned by Head Corporate Quality Compliance and CQA Travel Estimate Job Requirements Educational Qualification M Sc Microbiology Experience Tenure QC QA Professional in Microbiology Quality Assurance with 20 to 22 years of experience in microbiological sciences cGMP GLP pharmaceutical product test methods development and validation Document Process gap assessment Quality Assurance and Regulatory as well as Pharmacopeia Compliance Processes Known Aseptic Processing Terminal Sterilization BFS Technology Lyophilization Prefilled Syringes Oral Solid Dosages Oral Liquids Oral Powders API Certified by Indian FDA for microbiological and sterility testing Maintenance of cGMP Developing updating and reviewing Quality Systems Root Cause Investigations Implementation of CAPA activities OOS Deviation Management Compliant Handling Aseptic Process Simulation and Process Optimization 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