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    Analytical Development – Analytical Validation

    Amneal
    2+ years
    Not Disclosed
    Hyderabad
    10 Sept. 25, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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 Role: Analytical Validation
    Department: Analytical Development
    Location: Hyderabad

    Job Description:

    • Ensure compliance with cGMP and Good Laboratory Practices (GLP).
    • Maintain general cleanliness and organization of the laboratory.
    • Collaborate with quality control personnel to monitor exhibit batch analyses.
    • Prepare instrument methods, method sets, and review sample processing methods generated in Empower software.
    • Oversee analytical method transfer, verification, and validation.
    • Conduct analysis of raw materials, finished products, and packaging materials.
    • Prepare and review protocols for method transfer, verification, and validation.
    • Prepare and review reports related to method transfer, verification, and validation activities.
    • Review and maintain reconciliation of electronic data generated in the quality control laboratory during method validation, verification, technology transfer, and feasibility studies.
    • Investigate any laboratory incidents occurring during method transfer, verification, and validation, and prepare incident reports.
    • Archive and retrieve analytical development documents from the QA department.
    • Ensure overall compliance with analytical documents and records generated in the quality control laboratory.
    • Provide relevant documentation for regulatory filings.
    • Participate in internal and external audits.
    • Procure columns, chemicals, reference standards, and impurity standards for analytical method activities.
    • Initiate change controls and manage deviations/incidents.
    • Review specifications and Standard Test Procedures (STPs).
    • Respond promptly to regulatory queries.
    • Undertake additional activities as required by the Head of Department, following their instructions and guidance.

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