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Assistant Manager

Enzene Biosciences Ltd.
Enzene Biosciences Ltd.
7-12 years
Not Disclosed
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