Urgent) Executive

Job Title Sr Officer Executive QA Business Unit Global Quality Compliance Job Grade G12B G12C 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 or verification to ensure adequacy completeness and compliance of documents procedure practices etc Review of Batch Manufacturing Record BMR and Equipment Cleaning Record ECR prior to release of batch in SAP HANA as per current approved procedures To report Rejection Failure observation immediately Preparation and review of GMP documents related to activities 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 Follow the labelling and seal issuance procedure for materials after release rejection of batches Involved in dispatch activity and customer COA preparation to Verify certificate of analysis Equipment instrument and utilities etc qualification and re-qualification protocol and report review for manufacturing section To co-ordinate with change control team for the evaluation of change controls to refer for impact assessment and to derive action items Review and closure of the change controls action items in track-wise To escalate or highlight problems in QMS documents investigations BMR ECR and another document time to time To involve in training internal audits external audits Regulatory and customer Preparation and review of product quality review APOR POR and stated documents as per schedule monthly report and as and when required Responsible for co-ordination monitoring tracking participating etc in activities assigned for review verification to ensure adequacy completeness and compliance of documents procedure To monitor Tracking review closing of deviations Out of specification Investigation Corrective and Preventive actions Market complain Change controls etc to ensure adequacy in quality management system QMS Participation in various investigation processes including cross functional investigation to identify root cause and derive appropriate CAPA etc and closing the CAPA action QMS documents Responsible for co-ordination monitoring tracking and review of documents related to validations like process performance qualification cleaning validation Matrix continued process verification report esc GMP Walk round in manufacturing plants Quality Control Laboratory stores engineering as per schedule Review of annual summary reports for water systems and annual summary reports for environmental monitoring Travel Estimate Job Requirements Educational Qualification M Sc Organic Chemistry Analytical Chemistry Experience Tenure 5 to 8 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