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    Executive - G12a Qa

    Sun Pharma
    0-5 years
    Preffered by Company
    India
    10 Aug. 29, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any LifeScience Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Responsibilities:

    1. Audit Management:

      • Oversee and manage external and regulatory audits.
      • Ensure compliance and respond effectively to audit findings and inspections.

    2. Regulatory Compliance:

      • Maintain an overview of regulatory compliance requirements.
      • Conduct system gap assessments, escalate issues, and perform shop floor rounds as needed.

    3. Compliance and CAPA:

      • Actively participate in updating compliance measures through internal and external audits.
      • Oversee Corrective and Preventive Actions (CAPA) closure.

    4. Data Management:

      • Update and manage data in the master drive.

    5. Reporting and Documentation:

      • Prepare and review the site Quality Monthly Report.
      • Manage management review meetings.

    6. SOP and Documentation:

      • Prepare and review Standard Operating Procedures (SOPs).
      • Prepare and maintain the Site Master File.

    7. Quality Standards:

      • Review and identify gaps between Global Quality Standards/Global SOPs and Site SOPs.
      • Implement Global Quality Standards and SOPs at the site.

    8. Training and Development:

      • Develop and track the Departmental Annual Training Planner.

    9. Internal Audit:

      • Manage internal audit activities.

    10. Additional Responsibilities:

      • Perform other tasks as instructed from time to time.

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