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Analyst - Bioanalytical (Lc-Ms/Ms)

0-5 years
Not Disclosed
10 Dec. 23, 2024
Job Description
Job Type: Full Time Education: M.Sc. / B.Pharm / M.Pharm 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

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Preferred Skills

  • Qualification: M.Sc., B.Pharm, or M.Pharm.
  • Technical Expertise: Hands-on experience with LC-MS/MS.
  • Specialized Experience: Extensive experience in Method Development (MD) and Method Validation (MV) for bioanalytical methods.
  • Regulatory Knowledge: Strong understanding of bioanalytical GLP regulations and their application to handling bioanalytical projects.

Job Description

Key Responsibilities

  1. Method Development & Validation

    • Conduct method development and validation for bioanalytical methods.
    • Ensure study sample analysis aligns with applicable methods, protocols, SOPs, and regulatory guidelines.
  2. Equipment Operation

    • Operate key bioanalytical instruments, including HPLC, LC-MS/MS, and ELISA.
  3. Sample Analysis

    • Perform sample analysis and data compilation efficiently, adhering to applicable SOPs and timelines.
  4. Audit Compliance

    • Address relevant audit findings from QC/QA, ensuring corrective actions under the guidance of the project lead or group leader.
  5. Documentation

    • Prepare essential documents such as:
      • Standard Operating Procedures (SOPs)
      • Method SOPs
      • Bioanalytical Protocols/Plans
      • Method Validation Reports
      • Bioanalytical Study Reports
  6. Document Archival

    • Archive method and study-related documents post-QA review to ensure compliance and accessibility.

This role demands a proactive approach, attention to detail, and strong adherence to regulatory guidelines. If you are passionate about bioanalytical sciences and thrive in a structured environment, this opportunity is perfect for you!

Would you like to include additional details, such as application instructions or benefits?