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Executive - G12a Qa

0-5 years
Preffered by Company
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.