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Executive - Analytical Development

1+ years
Not Disclosed
10 Dec. 4, 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

Analytical Scientist – Method Development and Validation

Location:
Tandalja - R&D

Company:
Sun Pharmaceutical Industries Ltd


Job Responsibilities:

  • Regulatory Compliance:

    • Work as per cGMP standards and ensure compliance with current guidelines and SOPs.
    • Adhere to Quality Management Document (QMD) procedures.
  • Training & Reporting:

    • Complete training prior to task execution and maintain training records.
    • Escalate issues or incidents to the reporting manager for corrective actions.
  • Method Development & Validation:

    • Conduct method development studies for drug products and in-process materials.
    • Perform method validation for drug products and in-process materials.
  • Stability Studies:

    • Execute stability studies for drug products and in-process materials in alignment with organizational goals.
  • Instrument Management:

    • Perform instrument calibration and maintain instruments/equipment as per SOPs.
  • Study Documentation:

    • Prepare study protocols and reports.
    • Archive documents promptly as per SOP guidelines.
  • Safety & Waste Management:

    • Follow laboratory safety precautions and handle/dispose of waste properly.
  • Chemical Reference Standards:

    • Ensure qualification of reference standards, working standards, and chemical reference standard samples as per approved procedures.
  • Additional Duties:

    • Undertake responsibilities assigned by the reporting authority.