Deviation Management And Manufacturing Investigations

4 days ago


Bangalore Karnataka, India Syngene International Full time

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


  • Manufacturing manager

    9 hours ago


    Bangalore, India Biocon Biologics Full time

    Associate Manager - MSAT Bangalore, India Position Description: Biosimilar Mammalian MSAT Responsible for and single point of contact for downstream process from manufacturing plant Able to guide, train, mentor and manage team. Guiding teams to evaluate and execute new manufacturing technologies and effective transfer of processes and technologies....

  • Manufacturing Manager

    18 hours ago


    bangalore, India Biocon Biologics Full time

    Associate Manager - MSATBangalore, IndiaPosition Description:Biosimilar Mammalian MSATResponsible for and single point of contact for downstream process from manufacturing plant Able to guide, train, mentor and manage team. Guiding teams to evaluate and execute new manufacturing technologies and effective transfer of processes and technologies. Ensuring...


  • Bangalore, Karnataka, India Syngene International Full time

    Job Title Upstream Manufacturing Job Location Bangalore About Syngene Syngene is an innovation-led contract research development and manufacturing organization offering integrated scientific services from early discovery to commercial supply At Syngene safety is at the heart of everything we do personally and professionally Syngene has placed...


  • Bangalore, Karnataka, India Syngene International Full time

    Designation Downstream Manufacturing Job Location Bangalore About Syngene Syngene is an innovation-led contract research development and manufacturing organization offering integrated scientific services from early discovery to commercial supply At Syngene safety is at the heart of everything we do personally and professionally Syngene has...


  • Bangalore, Karnataka, India Syngene International Full time

    Designation Downstream Manufacturing Documentation Job Location Bangalore About Syngene Syngene is an innovation-led contract research development and manufacturing organization offering integrated scientific services from early discovery to commercial supply At Syngene safety is at the heart of everything we do personally and professionally ...

  • Sr Manager

    3 weeks ago


    Bangalore, India Wholsum Foods (Slurrp Farm and Mille) Full time

    Role Overview We are looking for a dynamic and hands-on Sr. Manager – Production & Manufacturing to lead operations across our network of co-manufacturing partners. This role is pivotal to ensuring seamless production execution, cost efficiency, and consistent quality delivery in a fast-growing FMCG environment. The ideal candidate is a strong executor...

  • Clinical Investigator

    2 weeks ago


    Bangalore, Karnataka, India Syngene International Full time

    Job Title Duty Doctor Job Location Semicon Park Electronic city phase II Department HPU About Syngene Syngene is an innovation-led contract research development and manufacturing organization offering integrated scientific services from early discovery to commercial supply At Syngene safety is at the heart of everything we do personally and...


  • Bangalore, Karnataka, India Syngene International Full time

    Designation Jr Manager Job Location Bangalore Reporting to Job Grade Jr Manager 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...

  • Executive

    2 weeks ago


    Bangalore, Karnataka, India Syngene International Full time

    Key Result Areas Role-specific Active involvement in all upstream manufacturing activities Perform error free operation by eliminating operational gaps in advance Active trouble shooting to minimize the various risks prior to execution and during execution Initiate and process upstream deviations investigations and closure Pre -execution activity ...


  • Bangalore, Karnataka, India Syngene International Full time

    Designation Upstream Manufacturing Documentation Job Location Bangalore About Syngene Syngene is an innovation-led contract research development and manufacturing organization offering integrated scientific services from early discovery to commercial supply At Syngene safety is at the heart of everything we do personally and professionally ...