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.

Role & responsibilities - Instrumentation Engineer:

• Assist in routine inspections, calibration, and preventive maintenance of laboratory instruments and equipment.
• Support troubleshooting activities and ensure timely repairs to minimize equipment downtime.
• Maintain accurate documentation of maintenance activities, equipment history, and service schedules.
• Ensure compliance with laboratory safety protocols, quality standards, and regulatory requirements.
• Coordinate with external vendors and service partners for specialized maintenance, calibration, and technical support.

Role & responsibilities - Lab Automation:

• To manage the sample manager LIMS for the overall Bioanalytical lab execution processes.
• Configurations of the lab execution method parameters in sample manager
• LIMS and other such software in coordination with vendor as per requirements.
• Preparation and configurations of the new methods for lab execution system based on method specific requirement.
• To update and configure the existing methods for lab execution system based on method specific requirement / based on revised SOPs.
• SOPs linked with automated processes.
• Execution for process implementation/ simplification /digitalization.
• To oversee and manage the implemented system / Software for effective and smooth operations.
• System evaluation of different vendors and conclude fit for business requirement.
• Document preparation for CSV Activities.

Role & responsibilities - LIMS Operator:

• Creation of Project, Study (Method Validation/Project Sample Analysis) and Master Assay based on Method SoP.
• To develop Study Design in the application based on protocol, Sample Handling and Tracking procedure as per sample shipment within system Based on request (from analyst) Analytical Run (work-list and run sequence) creation.
• Result import and perform Regression within system/application, Raw results generation (of Method Validation, Study Sample analysis, Reassay identification and Reassay report generation).
• To submit all reports to analysts and GL for their review.
• To generate final summary report tables (MV Reports and Study Reports) for compilation by report writers and sample concentration data (to Statistical department) for Pk Analysis.
• To generate Barcode labels through Watson LIMS for clinical phase study.

Role & responsibilities - Document Controller:

• Request to QAD for the requirement of controlled form, Log format, method book, SOP or other controlled documents.
• Maintain the copy of controlled form, SOP or other controlled documents.
• Issuance of controlled form to respective team for validation and project sample analysis as and when required.
• Maintaining the accountability of forms, format, log formats and method books.
• Maintain the copy of standard operating procedures within department.
• To return the obsolete / previous version SOPs to QAD when revised.
• To get the amended or extended SOPs stamped by QAD.
• Reconciliation and Archiving of raw data generated during MD, MV and PSA.
• Reconciliation and Archiving of calibration and maintenance data of equipments.
• Reconciliation and Archiving of log format, PTR, system related data and others.
• Archiving of all the respective data related to bioanalytical department