Sun Pharma is the largest pharmaceutical company in India and a leading global specialty generic player. With a strong presence in over 100 countries, Sun Pharma is committed to delivering high-quality, affordable medicines. The company’s R&D division focuses on innovation in drug development, bioanalytical research, and regulatory compliance.
Job Description: GLP Bioanalytical Executive
Key Responsibilities:
- Access and comply with Study Plans and Standard Operating Procedures (SOPs).
- Record and review raw data in compliance with Good Laboratory Practice (GLP) guidelines.
- Operate, maintain, and calibrate Liquid Chromatography and Tandem Mass Spectrometer (LC-MS/MS).
- Conduct method development, method validation, and study sample analysis for non-clinical GLP studies.
- Prepare Analytical Test Procedures (ATP), SOPs, and templates for GLP studies.
- Perform sample preparation for method development (MD), method validation (MV), and study analysis as per GLP guidelines.
- Maintain and calibrate pipettes assigned to the group.
- Prepare method validation/partial validation reports and bioanalytical study reports in consultation with the Study Director/Principal Investigator.
- Document and report deviations in GLP studies to the Study Director/Principal Investigator.
- Address QA observations for bioanalytical reports in compliance with GLP principles.
- Perform additional responsibilities as assigned by the reporting authority.
Qualifications & Skills:
- Education: M.Sc./M.Pharm in Analytical Chemistry, Pharmaceutical Sciences, or related field.
- Experience: Prior experience in GLP-compliant bioanalytical labs, LC-MS/MS operation, and method validation.
- Technical Skills:
- Strong knowledge of GLP, GCP, and regulatory guidelines.
- Hands-on experience with LC-MS/MS, HPLC, and sample preparation techniques.
- Proficiency in data documentation and report preparation.
- Soft Skills: Attention to detail, strong analytical skills, and effective communication.