המקום בו המומחים והחברות הטובות ביותר נפגשים
Teva Mgr Quality Function India, Maharashtra, Navi Mumbai 626664087
03.12.2024
How you’ll spend your day
- Co-ordinate with Project management Group (PMG) for compliance with the sponsor requirements and timelines.
- Provide periodic review on status of study files up to archival of files.
- Co-ordinate with Report Writing Group for the movement of files to the concerned department and ensuring to maintain timelines.
- To monitor and perform Quality Check of screening and all study activities from check-in, dosing, sample collection, processing, segregation, transfer and till checkout.
- To perform QC of ICF, compensation chart and review of CRF (versus Protocol), other study related documents prior to EC submission.
- To ensure that all the activities are performed by the delegated staff personnel in compliance with the EC approved protocol, GCP and relevant SOP’s and applicable regulatory requirement.
- Handling of monitor’s visits, maintaining of site visit log, resolution of all queries raised by the monitor/sponsor during his/ her site visit.
- Retrospective review of study documents to ensure adherence to required SOPs and regulatory requirements.
- To ensure all appropriate entries after documentation.
- Any discrepancies/ Deviations to be informed to Manager (if Required).
- Ensuring quality by reviewing all study related documents like ISF, Case Report Form binders, Study close out report, Sample Case record form, Study updates, medical screening record etc.
- Participation in internal and external audits by sponsors and other oversight entities such as FDA, EU, ANVISA.
- Review of SDTM & Clinic tables data with the source document.
- To verify the calibration and verification of instruments/equipment.
- To prepare & review standard operating procedures as delegated by PI or HOD or Manager.
Your experience and qualifications
- M. Pharm
- At least 12- 15 years of experience as a Quality Control in BABE Studies
משרות נוספות שיכולות לעניין אותך
