Key responsibilities:
* To perform the role as Compliance QA auditor to conduct system audits for Human Pharmacological Unit, to verify the compliance to ICH-GCP, 21 CRF Part 11 and applicable regulatory requirements. Collate data for quality metrics and report.
* Review the new and updated requirements of the standards/ guidelines/ regulations and assess in comparison with Syngene's systems. * Perform vendor audits based upon quality risk
assessment.
* Risk based review of system to ensure the critical
controls in computerized systems. * Comfortable working and communicating professionally with others to reach understanding and agreement as necessary.
If you possess a strong technical background in Good Clinical Practices and BABE studies, a deep understanding of Quality Systems (Change Control, Deviation, CAPA, Investigation), and preferably, knowledge of Process Excellence and Six Sigma, then
we'd love to hear from you.
Apply today and be part of our quality-focused team!
Mail Id: jaideep.k@syngeneintl.com Subject Line: Application for Compliance QA Auditor, GCP Quality! Work location: Bangalore
