Bioanalytical Qualility Control Executive

NAVITAS LIFE SCIENCES; Bengaluru; On-site; INR 600,000 - 900,000; Full time

Job summary

Navitas Life Sciences Pvt. Ltd. in Bengaluru seeks a Bioanalytical QC/QA professional to review chromatograms, calibration curves, QC samples, and analytical runs, ensuring data integrity and regulatory compliance.

The role requires meticulous data review and adherence to GLP/GCP guidelines for regulatory submissions. Key duties include audit readiness, protocol and report reviews, discrepancy investigations, CAPA tracking, and maintaining documentation.

Qualifications

• Degree in life sciences or pharmacy with relevant post-graduate qualification.
• 2–5 years of experience in Bioanalytical QC or Bioanalytical QA.
• Experience with LC-MS/MS and related bioanalytical techniques.
• Knowledge of GLP, GCP, FDA/EMA/ICH guidelines; familiarity with lab data systems.

Responsibilities

• Perform quality control review of bioanalytical data, including chromatograms, calibration curves, QC samples, and analytical runs.
• Review study protocols, analytical methods, validation reports, and sample analysis reports.
• Verify accuracy of calculations, data entries, and report contents.
• Ensure compliance with GLP, GCP, SOPs, and applicable regulatory guidelines.
• Review laboratory notebooks, raw data, worksheets, and electronic records.
• Identify discrepancies, deviations, and data inconsistencies; coordinate with laboratory teams for resolution.
• Support audit readiness and participate in internal and external audits.
• Maintain proper documentation and archival of QC-reviewed records.
• Track and monitor CAPA, deviations, and change control activities.
• Assist in the preparation and review of bioanalytical study reports for regulatory submissions.
• Ensure data integrity practices are followed throughout the analytical process.

Skills

Quality control review

Data review

Regulatory awareness

Education

M.Sc. / B.Pharm / M.Pharm / Biotechnology / Life Sciences or related discipline

Tools

LC-MS/MS

Job description

Role & responsibilities

• Perform quality control review of bioanalytical data, including chromatograms, calibration curves, QC samples, and analytical runs.
• Review study protocols, analytical methods, validation reports, and sample analysis reports.
• Verify accuracy of calculations, data entries, and report contents.
• Ensure compliance with GLP, GCP, SOPs, and applicable regulatory guidelines.
• Review laboratory notebooks, raw data, worksheets, and electronic records.
• Identify discrepancies, deviations, and data inconsistencies; coordinate with laboratory teams for resolution.
• Support audit readiness and participate in internal and external audits.
• Maintain proper documentation and archival of QC-reviewed records.
• Track and monitor CAPA, deviations, and change control activities.
• Assist in the preparation and review of bioanalytical study reports for regulatory submissions.
• Ensure data integrity practices are followed throughout the analytical process.

Preferred candidate profile

• M.Sc. / B.Pharm / M.Pharm / Biotechnology / Life Sciences or related discipline.
• 2-5 years of experience in Bioanalytical QC, or Bioanalytical Quality Assurance.
• Experience with LC-MS/MS and related bioanalytical techniques.
• Knowledge of GLP, GCP, FDA, EMA, and ICH guidelines.
• Familiarity with laboratory data systems and electronic data review.