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Executive

0-2 years
Not Disclosed
10 April 30, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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 Title:

Executive – GLP Bioanalytical


Company:

Sun Pharmaceutical Industries Ltd


Location:

Tandalja – Research & Development (R&D)


Posting Date:

April 30, 2025


Job Summary:

The Executive in the GLP Bioanalytical division at Sun Pharma’s Tandalja R&D site will be responsible for conducting method development, validation, and non-clinical study sample analysis in compliance with Good Laboratory Practice (GLP). The role involves instrument handling, documentation, QA compliance, and contributing to bioanalytical reporting.


Key Responsibilities:

  • Access and follow Study Plans and Standard Operating Procedures (SOPs).

  • Record raw data accurately and promptly in accordance with GLP.

  • Operate, maintain, and calibrate LC/MS/MS (Liquid Chromatography-Tandem Mass Spectrometry) instruments.

  • Conduct method development, method validation, and non-clinical study sample analysis for GLP studies.

  • Prepare ATPs (Analytical Test Procedures), SOPs, and templates related to GLP bioanalytical work.

  • Perform sample preparation for MD (Method Development), MV (Method Validation), and study analysis per GLP guidelines.

  • Maintain and calibrate pipettes used in the group.

  • Prepare method validation reports, partial validation reports, and bioanalytical study reports under guidance of Study Director/Principal Investigator.

  • Document any deviations in GLP studies and report directly to the Study Director and/or Principal Investigator.

  • Respond to QA audit observations in compliance with GLP.


Required Skills and Attributes:

  • Hands-on experience with LC/MS/MS operation and troubleshooting.

  • Knowledge of GLP principles and bioanalytical method validation.

  • Proficient in scientific documentation and report writing.

  • Strong understanding of regulatory requirements in bioanalytical studies.

  • Attention to detail, quality-oriented, and a collaborative mindset.