Manager

Job Title Manager-2 Business Unit Sun Global Operations Job Grade G11B Location Sikkim Unit II Sr No Responsibilities 1 To monitor all activity in QC department as per GLP 2 To ensure the proper closing of OOS Lab Incident OOC OOT Batch Rejection RM PM FP Stability on time 3 To review the OOS Lab Incident OOC OOT Non conformities and ensure that the defined procedure as followed by QC to identify the root cause and establishment of CAPA 4 To review the Log books Formats Electronic Paper raw data generated in QC lab as a secondary check by QA of QC 5 To Prepare review of trend of all laboratory errors and effective CAPA implementation to reduce laboratory errors 6 To monitor that completion of Analyst Qualification prior to assign work to analyst 7 Periodic review of Data Integrity and shop floor inspection of Lab as per predefined procedure 8 To review and approve the Reduce Testing protocol as per SOP 9 To Approve COA through LIMS for Batch release 10 To Review CSV documents as process quality Lead 11 To Monitor all the document review related activity under analytical QA 12 To Approve LIMS audit trial for pending samples in monthly basis 13 To review and Approve Message centre audit trial on daily basis 14 Responsible for all aspects of quality assurance in quality control laboratories w r t to assessment of quality issues in labs review of documentation compliance in QC labs QC lab readiness for inspection and contract testing lab management at the Site as per current Good Manufacturing Practices requirements 15 Maintain proper online implementation of SOPs CAPA and Preventive Maintenance through proper training 16 Ensure compliance of the functional area with company Health and Safety Policies 17 Special Projects Ensure support of special project through timely implementation in QA per project timelines 18 Ensure people development initiatives and training are implemented within QA 19 Completion of individual training requirements with in timeline 20 To ensure the audit compliance 21 To review the change control of QC and ensure its closer and implementation verification 22 Preparation of Monthly data for laboratory error for CQA Reporting 23 Execute assigned activities within established timeframe SOPs revised in a month SOPs revision pending beyond timeline 24 Execute assigned activities correctly first time right 25 Ensure compliance against Internal External audit observations 26 Support and maintain target on Global metrics related to QA Compliance and Audit 27 Ensure proper online implementation of SOPs CAPA related to Internal Audit other Audit and Preventive Maintenance through proper training 28 Maintain inspectional readiness within the functional area Maintain collaboration with QA and other department to ensure successful regulatory customer inspection with no critical findings or repeat observation 29 Ensure compliance of the functional area with company Health and Safety Policies 30 Any other work assigned by HOD Travel Estimate Job Requirements Educational Qualification B Pharm Experience Tenure 12-15 years of experience in pharmaceutical industry 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