Manager Corporate Quality Audit

Title Manager Corporate Quality Audit Business Unit Corporate Quality Audit Job Grade Manager G11 G10 Location Mumbai Sun House 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 JOB DESCRIPTION Job Summary To ensure that SUN Pharma Quality and Compliance Standards and applicable global regulatory authorities requirements are met and that all SUN affiliates Third parties Suppliers and SUN sites Operational Units to achieve maintain and improve the adequate level of compliance through independent auditing and follow-up Essential Job Functions To conduct thorough GMP Audit of Contract Manufacturing Organization CMO sites involved in manufacturing of different dosage forms including Biologics to ensure that they always deliver high quality and standard products and remain compliant with GMP requirements To conduct GMP audits of RM PM Vendors Manufacturer To co-ordinate with CMO sites 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 communicate the outcome of CMO vendor audit based on the risk associated with the patient regulatory compliance and business risk to facilitate making decision of Vendor Approval Dis-approval To make sure that CMO sites and Affiliate Companies are prepared for Regulatory Agency Inspections e g through Mock inspections audits and supports activities whenever required 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 ensure during audit that non-compliances to the requirements stated in various guidelines have been identified 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 Trending the audit observations and highlighting the areas for improvement 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 CMO risk assessment Requirements and Qualifications Industrial Experience Knowledge R D Production Quality Assurance experience in Bio-pharmaceutical Pharmaceutical with 13 10 years of experience ISO 9001 2015 certified lead Auditor Processes Known Inspection readiness Life cycle of the product from process development phase to commercialization phase with successful clearance of regulatory inspection Succeeding cGMP Root Cause Investigations Implementation of CAPA OOS Deviation Management Change management Auditing Compliant Handling and Process Optimization Travel Estimate Low Job Requirements Educational Qualification Bachelors or Masters degree Experience 13 years experience 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