Deviation Management And Manufacturing Investigations
4 weeks ago
JOB DESCRIPTIONDesignation Deputy ManagerLevel 7- IIJob Location BangaloreThe CompanySyngene 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 Key Result AreasRole-specific Functional 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 xc2xb7 Ensure timely proposal and implementation of appropriate CAPA for any audit findings xc2xb7 Perform timely tracking of Operational and Compliance Metrics for Manufacturing Operations and management reporting xc2xb7 Ensure Risk Management for Biologics Operations covering following elements and ensure proposal and implementation of appropriate risk mitigation actions CAPA Quality and Compliance Risks o Operational Risks o Data Integrity Risks xc2xb7 Perform and support timely preparation review and approval of GMP documentations xc2xb7 Conduct and or support training on SOPs protocols and On-the-Job activities xc2xb7 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 EmployerIt 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
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