Quality Assurance (Analytical/In Vitro)
VitelyBio
Date: 1 day ago
City: Ahmedabad, Gujarat
Contract type: Full time
- Understanding of current regulatory expectations associated with In-Vitro BE studies (e.g., IVRT, IVPT, InVitro Binding, BCS Biowaiver, etc.) and analytical services associated with pharmaceutical products including Microbiological tests.
- Review of Method Validation / Study Sample Analysis Protocols, Method SOP, Raw Data, and Reports for InVitro Analysis like IVRT, IVPT, BCS Biowaiver and Analytical activities, Microbiological activities, etc.
- Review of Technical SOPs, Prepare / Review Quality Assurance Related SOPs or other documents and their further controlling and issuance.
- Tracking and Review of QMS tools like Change Control, Deviations, CAPA, Incidents, Events, etc.
- Verify Sample / Investigational Products Receipt, Dispending, Return, Discard, etc. related activities and provide line clearance for the dispensing of Samples / IPs.
- Review of Instrument Qualification, Calibration, Preventive Maintenance, etc. data/reports.
- Perform Data Archival, Retrieval, Environmental Monitoring, and overall maintenance of the Archival Area.
- To plan and perform Internal Audits including InProcess Audits, System Audits, etc.
- Perform and Manage Vendor Qualification for the intended services.
- Review of Computer System Validation Documents i.e., Software IQ, OQ, PQ etc. Interested candidates can send their resume at [email protected]
- Timely completion of assigned tasks within defined timelines and provide regular updates to reporting manager.
- To participate in regulatory and or sponsor audit and to be involved in the preparation and review of response for submission to regulatory agency and/or sponsor.
- Any other responsibilities assigned by reporting manager
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