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Analyst - Bioanalytical (Lc-Ms/Ms)

0-5 years
Not Disclosed
10 Feb. 10, 2025
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

Preferred Skills:

  • Qualification: M.Sc. / B.Pharm / M.Pharm
  • Handling experience on LC-MS/MS
  • Extensive experience on MD/MV of Bioanalytical Methods
  • Well versed with bioanalytical, GLP regulations for handling bioanalytical projects

 

Job Description:

  • Perform method development, method validation and study sample analysis in compliance with applicable methods, protocols, SOPs, and regulatory guidelines.
  • Operation of key bioanalytical equipment’s like HPLC, LC-MS/MS and ELISA
  • Perform sample analysis and compilation of data in timely manner in line with applicable SOPs.
  • Responsible for compliance to relevant audit findings from QC/QA and take appropriate actions in relation to audit findings with guidance of project Incharge/ group leader.
  • Preparation of Standard Operating Procedure (SOPs), Method SOPs, bioanalytical protocols/plan, method validation reports and bioanalytical study reports.
  • Archival of method and study related documents after completion of QA review.