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Analytical Development – Analytical Validation

Amneal
Amneal
2+ years
Not Disclosed
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.