Teva Pharmaceuticals Quality Analyst Job For Pharma, Apply Online
Looking for a career in quality assurance? Teva Pharmaceuticals is hiring a Quality Analyst I in Navi Mumbai, India. As a global leader in generic and essential medicines, Teva is committed to delivering high-quality healthcare solutions. This role offers an exciting opportunity to audit bioanalytical studies, ensure regulatory compliance, and contribute to the integrity of BA/BE research. If you have 3-5 years of experience and a background in Organic or Analytical Chemistry, apply now and be part of a mission-driven company shaping global healthcare.
Company: Teva Pharmaceuticals
Job Post: Quality Analyst I
Location: Navi Mumbai, India, 400706
Job Id: 60702
About Teva Pharmaceuticals
Teva Pharmaceuticals is on a mission to make good health more affordable and accessible, helping millions around the world enjoy healthier lives. With a presence in nearly 60 countries and a diverse workforce, we are the leading manufacturer of generic medicines and a proud producer of essential medicines listed by the World Health Organization. Every day, over 200 million people worldwide take our medicines, and we are always seeking new ways to make a difference and welcoming individuals who share our mission.
Job Description
How you’ll spend your day as Quality Analyst in Navi Mumbai
:- Audit the Bioanalytical phase of BA/BE studies 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 give comments on the same.
- To review the change control and deviations as and when assigned.
- Prepare audit reports to adhere to the guidelines, written procedures, and regulatory inspections and ensure compliance from the user department to audit reports.
- To review method SOPs as and when assigned.
- Conduct in-process study audits in order to ensure compliance with GCP/GLP Protocols, SOPs, and applicable regulatory requirements.
- Audit of generated raw data and respective validation report, addendum, the bioanalytical report generated from method validation, partial method validation, and subject sample analysis of the clinical study.
- To share QA audited concentration data with the Biostatistician as per business timelines.
- To audit of PK and statistical output of clinical study as per the requirement.
- To audit Bio-summary tables (OGD), eCTD compilation of clinical studies.
- Review the overall study through an audit of ongoing studies, reports, and documentation and release the study-specific audit certificate.
- Coordinate with the user department and medical writer for finalization of bioanalytical reports and clinical study reports.
- Review of audit trail on LC-MS/MS instrument.
- To conduct area-specific audits, system audits, and vendor audits as and when assigned.
- To audit calibration records/ qualification records of instruments/equipment for bioanalytical as and when assigned.
- Control and issue the documents, i.e., SOPs, forms, formats, logbooks, study-specific protocols, validation protocols, and qualification protocols of all departments of WPPL.
Your experience and qualifications for Quality Analyst in Navi Mumbai
- B.Pharm, M.Pharm OR M.Sc
- 3-6 Years of experience in Bioanalytical Quality Assurance for a BABE Study
Keywords: Bioanalytical Quality Analyst, Quality Assurance, Teva Pharmaceuticals, Job Posting, Navi Mumbai, India. Teva Pharmaceuticals Quality Analyst Job For Chemistry, Apply Online
