Bioanalytical Monitor - Executive
Exemed Pharmaceuticals
- Location
- Vadodara, Gujarat, India
- Job type
- Full-time
Required skills
- acceptance criteria
- compliance
About the role
Exemed Pharmaceuticals
Website:
exemedpharma.com
Job details:
- Review method development, method validation and study sample analysis in compliance with applicable methods, protocols, SOPS, and regulatory guidelines.
- Operation of key bioanalytical equipment's like HPLC, and LC-MSfMS.
- Review sample analysis and compilation Of data in timely manner in line with applicable SOPS.
- Responsible for compliance to relevant audit findings from QC/QA and take appropriate actions in relation to audit findings with guidance of my Manager.
- Review of Standard Operating Procedure (SOPs), Method SOPS, bioanalytical protocols/plan, method validation reports and bioanalytical study reports.
- Provide reference standards, internal standards, and relevant compound for method development and validation.
- Coordinate with the clinical site to ensure timely shipment of plasma/biological samples to the Bioanalytical facility under required storage conditions.
- Ensure the CRO adheres to GLP and applicable regulatory guidelines (e.g., USFDA, EMA, DCGI) for bioanalytical studies).
- Maintain regular communication with the CRO to monitor Study progress and ensure alignment with project timelines.
- Review and provide final approval of the Bioanalytical Study Report, ensuring it is complete, accurate, and meets regulatory standards.
- Ensure all bioanalytical methods are scientifically sound and aligned with current regulatory guidelines.
- Address Out-of-Specifieation (OOS), failed runs, Or method deviations promptly With CRO). Review bioanalytical raw data, chromatograms, and analytical summaries.
- Ensure all runs are reviewed and accepted as per acceptance criteria.
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