Senior Executive

Job Title Executive Sr Executive QA Business Unit Global Quality Compliance Job Grade G12A G11B Location Ahmednagar Ahilyanagar 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 Responsible for co-ordination monitoring tracking participating etc in activities assigned for review verification to ensure adequacy completeness and compliance of documents procedure practices etc To monitor tracking review closure of deviations Out of specification Investigations Corrective and Preventive actions Market complaint Change controls etc to ensure adequacy in quality management system QMS Ensure effective implementation of Quality Management system at site and to monitor QMS activities in Track wise software To escalate or highlight problems in QMS document and investigation in time Review of data with evaluation to support of QMS documents like Change controls deviations CAPAS OOS Laboratory Events monitoring of Preventive Maintenance qualification etc Responsible for co-ordination monitoring tracking and review of documents related to validations like process performance qualification cleaning validation Matrix continued process verification report etc To provide the required details data related to QMS for the preparation of APQR monthly report and as and when required Preparation review of APQR Preparation guidance and review of Quality Risk Management evaluation of risk involved in manufacturing activities received manufactured material related to audit compliance failure gaps of existing system activities related to laboratory controls etc Review of change controls received from different departments viz process equipment facility SOP specification etc for its appropriate evaluation justification and its classification to identify and communicate the action items derived based on the assessment to all the concern wake holder through Trackwise Providing the status of QMS records like change controls deviations etc as an when required to management through Quality metrics data gathering etc and to conduct the meeting for its progress and timely closure Coordinating and reviewing technology transfer activity and ensuring availability of required documents as per respective SOP Review of Batch Manufacturing Record BMR and Equipment Cleaning Record ECR prior to release of batch in SAP HANA as per current approved procedures Release Reject of material batch in SAP HANA after ensuring related relevant documents and system related records through Trackwise about change control deviation Lab event OOS OOT closed etc are closed prior to approval Activities related to updation transactions in SAP System Perform the product change over clearance activity in manufacturing packing repacking area To operate various software such as Trackwise SAP LIMS BRMS EDAMS EDMS etc Travel Estimate Job Requirements Educational Qualification M Sc Organic Chemistry Analytical Chemistry Experience Tenure 7 to 9 yrs experience in API manufacturing Units in Quality dept 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