25 Sep
|
Veeda CR
|
Ahmedabad
25 Sep
Veeda CR
Ahmedabad
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.
📌 Walk In - Fresher - Analyst, BQM & Custodian - BRD (Ahmedabad)
🏢 Veeda CR
📍 Ahmedabad