Fresher - Walk In - Analyst, BQM & Custodian - Bioanalytical Research

Veeda CR

0 years

2 - 3 Lacs

ahmedabad

Posted:Just now| Platform:

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Skills Required

mass spectrometry lcms method validation analytical research sample analysis method development

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities - Analyst

Perform bioanalytical analysis of biological samples (plasma, serum, urine, tissue, etc.) using techniques such as LC-MS/MS & HPLC.
Support method development, optimization, and validation as per regulatory guidelines (US FDA, EMA, GLP).
Conduct routine sample preparation, extraction, and data acquisition.
Maintain accurate documentation including raw data, analytical reports, and laboratory notebooks.

Role & responsibilities - BQM

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, verify, and log biological samples (plasma, serum, urine, tissue, etc.) as per study protocols.
Ensure proper labeling, segregation, and storage of samples under specified conditions.
Maintain accurate chain-of-custody records and sample inventory logs.
Monitor and document freezer temperatures and alarm systems.
Control access to sample storage areas to maintain sample integrity and security.
Coordinate sample issuance and reconciliation with analysts and project teams.

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