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Subject Matter Expert - Deviation Management and Manufacturing Investigations

6.00 to 10.00 Years   Delhi   19 May, 2023
Sygene
Job LocationDelhi
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaFinance / Accounts / Tax
EmploymentTypeFull-time

Job Description

    Maintain Biopharmaceutical Development Labs In state of safety Compliance. Primary Responsibilities
    • Timely reporting of deviations and perform appropriate investigations to identify root cause or most probable root cause and proposal & implementation of appropriate CAPA to prevent reoccurrence.
    • Perform appropriate manufacturing investigations for OOS results and Customer Complaints to identify root cause or most probable root cause and proposal & implementation of appropriate CAPA to prevent reoccurrence.
    • Participate in the audits as SME for OOS investigations and manufacturing investigations.
    • 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.
    • Timely proposal and implementation of appropriate CAPA for audit findings.
    • Participate in regular facility walkthroughs and internal audit for Biologics Operations to ensure adherence to the implemented systems and compliance with regulatory requirements including Data Integrity assessment.
    • Support for implementation of Operational Excellence Initiatives for the Operating Unit (OU).
    Functional or Technical skills RequiredExcellent technical writing and presentation skills. Hands-on experience on GMP Investigations with use of Root Cause Analysis (RCA) tools will be preferred. Excellent communication and conflict management skills. Knowledge and experience on the concept of Risk Management (System Level, Component Level and/or other suitable tools) Working experience with cross functional teams. Education
    • M.Sc/B.Pharma/B.Tech
    • Relevant experience 6 to 12 years of experience
    ,

Keyskills :
reportingroot cause analysiscontinuous improvement facilitationroot causesmequalityanimal healthenvironmental impact assessment

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