Company: Quantys Clinical Pvt Ltd
Position: Research Associate (Quality control reviewer) – Bioanalytical
Experience: 2-5 Years in CRO
Roles and Responsibilities:
- Review of data generated from Method development, Method validation and Subject Sample Analysis activities as per SOP and regulatory compliance.
- Review of Master calibration schedule of Instruments and Equipment’s and review of all calibration status and records (Internal and External).
- Verify the accountability and records of all working standards including controlled substances.
- Review of Method Validation Report and Bioanalytical study reports as per Regulatory submission requirement.
- Online review of raw data for completeness and accuracy of data generation, compilation and compliance to SOP/ protocol.
- Ensure that all audit trails are thoroughly reviewed and any discrepancies if found are immediately escalated to department head and reporting manager.
- Regular auditing of BA activities and prepare the compliance reports.
- Implement and follow line-clearance procedure for enabling systematic approach and ensure online completion of related documentation and ensure for Good Laboratory Practice (GLP) compliance & Good Documentation Practices (GDP).
- Assist the reporting manager in on-boarding new employees by ensuring that the training requirements are identified and met.
- Keep track and send written reminders to analysts, system operators and group leaders on upcoming SOP revisions, scheduled calibrations, preventive maintenance and other time bound activities.
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