Sme- Deviation Management And Manufacturing Investigations

JOB DESCRIPTION Designation SME- Deviation Management and Manufacturing Investigations Job Location Bangalore The Company Syngene International Ltd BSE 539268 NSE SYNGENE ISIN INE398R01022 is an integrated research development and manufacturing solutions company serving the global pharmaceutical biotechnology nutrition animal health consumer goods and specialty chemical sectors Syngene s 4500 scientists offer both the skills and capacity to deliver great science robust data management and IP security and quality manufacturing at speed to improve time-to-market and lower the cost of innovation With a combination of 1 9 Mn sq ft of specialist discovery development and manufacturing facilities as well as dedicated research facilities for Amgen Baxter Bristol-Myers Squibb and Herbalife Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA At Syngene safety is at the heart of everything we do personally and professionally Syngene has placed safety at par with business performance with shared responsibility and accountability including following safety guidelines procedures and SOPs in letter and spirit Common Responsibilities Responsible accountable towards safety compliance in all the work activities in the own responsibility area s Monitor confirm that the established Environment Occupational Health Safety and Sustainability EHSS practices for safe work environment is followed self direct reports Monitor confirm that self direct reports adhere to the highest standards of quality integrity compliance for every work activity GMP compliance in all the training activities and meeting training requirements Adherence to Standard Operating Procedures and Operational Control Procedures Support for QMS initiation and on-time closure activities Safety and DI Responsibilities Adhere to organizational policies procedures on EHSS POSH Data Integrity and IT security Always wear the applicable PPEs and adhere to any other Environment Health and Safety EHS requirements in the workplace for individuals lab plant safety Understand all necessary safety protocols and always follow the same to ensure safety for all Proactively identify near-misses potential incidents and communicate to supervisor and or line manager or through the respective web portals Specific Responsibilities Ensure timely reporting of deviations appropriate investigations to identify root cause or most probable root cause and proposal implementation of appropriate CAPA to prevent reoccurrence Perform the manufacturing investigations for OOS results and Customer Complaints to identify root cause or most probable root cause and facilitate proposal implementation of appropriate CAPA to prevent reoccurrence Participate in the audits and inspections as SME for deviation management and manufacturing investigations Ensure timely proposal and implementation of appropriate CAPA for any audit findings Perform timely tracking of Operational and Compliance Metrics for Manufacturing Operations and management reporting Ensure Risk Management for Biologics Operations covering following elements and ensure proposal and implementation of appropriate risk mitigation actions CAPA Quality and Compliance Risks Operational Risks Data Integrity Risks Perform and support timely preparation review and approval of GMP documentations Conduct and or support training on SOPs protocols and On-the-Job activities Participate in regular facility walkthroughs Self-Inspection and Internal Audit for Biologics Operations to ensure adherence to the implemented systems and compliance with regulatory requirements including Data Integrity assessments Support for implementation of Operational Excellence Initiatives for the Operating Unit OU Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity EEO to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by applicable legislation or local law In addition Syngene will provide reasonable accommodations for qualified individuals with disabilities Pls visit us at to know more about us and what we do