- Audit each Clinical phase of BA/BE studies (both pre and post study) to assure the management that the facilities, personnel, equipment, instruments, protocols, methods, practice, records and controls are in conformance with the relevant and current GCP / applicable GLP guidelines, protocols and SOPs implemented as per SOP.
- Review the SOPs, forms, formats and logbooks of the department(s) and give comments on the same.
- To control and issue the documents i.e., forms, formats, logbooks, study specific protocols, qualification protocols of respective departments of WPPL as per SOP.
- To review the change control and deviations (including study specific deviations) as and when assigned.
- Prepare audit report to adhere with the guidelines, written procedures and regulatory inspections and ensure compliance from user department to audit reports.
- Conduct the in-process, retrospective audits of clinical phase of study in order to ensure the compliance to GCP/GLP, Protocols, SOPs and applicable regulatory requirements as and when study is assigned.
- To review calibration records/qualification records of instruments/equipment is for clinical and pathology laboratory as when assigned.
- Review and audit medical screening records, case record forms, ICFs and other raw data generated during conduct of clinical study as per SOP.
- To audit the SDTM data of clinical studies for regulatory submissions.
- To audit of WinNonlin data, Pharmacokinetic analysis and statistical output of clinical study as per the requirement.
- To audit Bio summary tables (OGD), eCTD compilation of clinical studies as per assignment.
- To share the pharmacokinetic sampling sheets of respective studies to the Biostatistician.
- M. Pharm / M.Sc
- 5+ years of experience into Clinical QA Auditor
Quality Analyst II - Navi Mumbai, India - Teva Pharmaceuticals
Description
Who we are
Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.
How you'll spend your day
Your experience and qualifications