Quality Analyst II

Company Info

Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Job Description

• Responsible for planning and executing the QA activities for Extractable and Leachable Lab (E&L).
• Conduct in-process audits, internal study audits, and system audits to ensure compliance with GLP, Protocols, SOPs and applicable regulatory requirements.
• Review of raw data of respective project book, method validation, partial method validation, study as and when assigned. Monitor the Extractable and Leachable Lab projects to ensure that all the data is audited before submission of study report to sponsor.
• Audit the equipment qualification, calibration and preventive maintenance documents and check whether these are conducted as per scheduled.
• Report on the performance of the quality system to the Head-QAU for review and as a basis for improvement of the system.
• Co-ordinate with internal and external stake holders on matters relating to quality system of E&L Lab.
• Review the SOPs and working documents of E & L lab and provide comments on the same prior to approval.
• Evaluate and track Change Control of E &L lab.
• To issue controlled/uncontrolled documents pertaining to E&L Lab.
• Perform Gap assessments for TEVA policies and standards and implementation of QMS related to E&L lab as and when required.

Qualifications

• M Pharm/or MSc Analytical chemistry
• Experience-5-7 years

Function

Sub Function

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Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva’s global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.