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    Assistant Manager

    Enzene
    7-12 years
    Not Disclosed
    India
    10 Aug. 22, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate 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

    Job Summary:

    Role: Assistant Manager
    Department: Quality Assurance
    Location: Unit 1
    Educational Qualification: [To be filled based on the specific requirement]
    Experience Required: 7-12 years

    Job Description:

    1. Document Control:

      • Review and approve SOPs, BMRs, and other quality documents.
      • Check and review raw data and batch release data to ensure data integrity and correctness.
      • Maintain soft copies of documents on the server.

    2. Change Control, Deviation, and CAPA:

      • Review Change Control, Deviations, and CAPAs.

    3. Self-Inspection:

      • Prepare inspection schedules.
      • Execute audits according to the schedule.
      • Prepare and close out inspection reports.

    4. Vendor Qualification:

      • Conduct vendor assessments and audits.
      • Sign Quality Agreements with vendors.

    5. Validation Activities:

      • Assist in validation activities at the manufacturing site.
      • Review qualification and validation documents.

    6. Cell Bank Control:

      • Oversee the receipt, storage, and documentation of cell banks.

    7. GMP Compliance:

      • Monitor current Good Manufacturing Practice (cGMP) compliance within the unit.

    8. Authorization:

      • Authorize QA documents as recommended by the Head of QA.

    9. IPQA and Batch Release:

      • Manage batch release processes.
      • Review and ensure compliance with IPQA observations.

    10. Market Complaints and Recalls:

      • Handle market complaints, recalls, and returns.

    Skills Required:

    • Batch Release
    • Shop Floor Investigation
    • PQR (Product Quality Review)
    • Batch Record Review

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