Teva Pharma Quality Analyst Jobs – Apply Online
Quality Analyst I
Date: Dec 18, 2024
Location: Navi Mumbai, India, 400706
Company: Teva Pharmaceuticals
Job Id: 59819
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
- Audit each BA/BE study (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.
- Review the SOPs, forms, formats, and logbooks of all the department(s) and provide comments on the same.
- Review the change control and deviations as and when assigned.
- Prepare audit reports to adhere to guidelines, written procedures, and regulatory inspections, ensuring compliance from the user department to audit reports.
- Review method SOPs as and when assigned.
- Conduct in-process study audits to ensure compliance with GCP/GLP, Protocols, SOPs, and applicable regulatory requirements.
- Audit generated raw data and respective validation reports, addenda, bioanalytical reports generated from method validation, partial method validation, subject sample analysis of clinical study.
- Share QA audited concentration data with Biostatisticians as per business timelines.
- Audit PK and statistical outputs of clinical studies as per the requirement.
- Audit Bio-summary tables (OGD), eCTD compilation of clinical studies.
- Review overall study through audits of ongoing studies, reports, and documentation, and release the study-specific audit certificate.
- Coordinate with the user department and medical writers for finalization of bioanalytical reports and clinical study reports.
- Review of the audit trail on LC-MS/MS instruments.
- Conduct area-specific audits, system audits, and vendor audits as and when assigned.
- Audit calibration records/qualification records of instruments/equipment for bioanalytical as and when assigned.
- Control and issue documents such as SOPs, forms, formats, logbooks, study-specific protocols, validation protocols, and qualification protocols for all departments of WPPL.
Your experience and qualifications
- B.Pharm, M.Pharm OR M.Sc
- 3-6 Years of experience in Bioanalytical Quality Assurance for a BABE Study
Link to apply: APPLY ONLINE HERE
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