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Executive

0-5 years
Preffered by Company
10 Aug. 29, 2024
Job Description
Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any LifeScience 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

Responsibilities:

  1. Study Plan and SOP Compliance:

    • Access and adhere to the Study Plan and Standard Operating Procedures (SOPs).
    • Follow all instructions detailed in the Study Plan and SOPs to ensure compliance.
  2. Data Recording and Quality:

    • Record raw data promptly and accurately, adhering to the Principles of Good Laboratory Practice (GLP).
    • Review raw data to ensure quality and accuracy, taking responsibility for data integrity.
  3. Instrumentation Operation and Maintenance:

    • Operate, maintain, and calibrate Liquid Chromatography and Tandem Mass Spectrometry (LC/MS/MS) equipment.
  4. Method Development and Validation:

    • Perform method development, method validation, and study sample analysis (non-clinical) in accordance with GLP guidelines.
  5. Documentation and SOP Preparation:

    • Prepare Analytical Test Procedures (ATPs), SOPs, and templates for GLP studies.
    • Maintain and calibrate pipettes as assigned to the group.
  6. Sample Preparation:

    • Prepare samples for method development (MD), method validation (MV), and study analysis following GLP guidelines.
  7. Reporting and Documentation:

    • Draft method validation or partial method validation reports and bioanalytical study reports in consultation with the Study Director or Principal Investigator, ensuring compliance with GLP principles.
    • Document and communicate any deviations in the GLP study report directly to the Study Director or Principal Investigator as appropriate.
    • Address and respond to Quality Assurance (QA) observations on bioanalytical reports in consultation with the Study Director or Principal Investigator, maintaining adherence to GLP principles.
  8. Additional Responsibilities:

    • Undertake any other tasks or responsibilities assigned by the reporting authority.