Walk In - Fresher - Analyst, BQM & Custodian - BRD

Role & responsibilities :

Role & responsibilities - Analyst:

• Collect samples for analysis from custodian.
• Processing of sample by using various sample extraction technique (to determine the concentration of analyte).
• Perform analysis via LCMS. Follow GXP.
• Sample extraction process using LLE, SPE, PPT.
• Stability issue handling, derivatization, etc. approach.
• Receive controlled forms for various activities.
• Document all linked activities and forms as per SOP.
• To check documents done by Jr. Analyst/ Fresher.
• Method development skills
• Trouble shooting of method
• Excel and MS Word.

Role & responsibilities - BQM(QC):

• Perform Quality review of bioanalytical data, including chromatograms, calibration curves, QC samples, and final reports.
• Review bioanalytical method validation (BMV), partial validation, and cross-validation reports for compliance with regulatory guidelines.
• Ensure adherence to GLP, GCP, US FDA, EMA, and CDSCO requirements.
• Verify data integrity (ALCOA+) and ensure traceability of raw data.
• Review study plans, protocols, SOPs, and amendments.

Role & responsibilities - Custodian:

• Receive, label, log, store, and retrieve biological samples (plasma, serum, urine, tissue, etc.) as per SOPs.
• Receive, label, log, store, retrieve working and reference standards and Analytical Columns as per SOPs.
• Maintain sample storage areas such as deep freezers, refrigerators, and cold rooms under defined conditions.
• Monitor and record storage temperatures; report deviations immediately.
• Ensure proper segregation, handling, and disposal of biohazard and chemical waste.
• Maintain accurate inventory records, sample chain-of-custody logs, and tracking documentation.