QUALITY ANALYST III

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 1) Review / Approval of Nitrosamines related  documents.
Analytical Development Report, Method Validation Protocols and Reports.
Nitrosamine risk assessment 2) Review / Approval of Computer System Validation related activities in gALM.
3) Release / Reject of batches manufactured for clinical study.
4) Review / Approval of Qualification documents for new instrument/ equipment.
5) Implementation of Corporate policies / standards at site.
6) Review, evaluation and approval of QMS documents i.
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change controls / deviations / LIR / chromatographic errors etc.
7) Review / approval of Investigations, CAPA, LIR in Trackwise system.
8) Ensure CAPA actions based on the investigation root cause are identified and implemented.
9) Preparation of trends for non–conformance.
10) Self-inspection of various departments to check compliance with GxP, SOPs and applicable regulatory requirements.
11) Compilation of Site Quality Council Report and presentation of data on monthly basis.
12) Review of Risk Assessments, Quality Technical Agreements between Teva and various contract laboratories, Intra Company- Quality Technical Agreement (IC-QTA).
13) Review / Approval of specifications, Method Validation Protocols / Reports, Method Transfer Protocols / Reports, ADR, PDR, Study Protocol / Reports etc.
14) Perform audit of Contract Laboratories, Third party vendor in co-ordination with Subject Matter Expert.
15) Support during regulatory and other inspections at site.
16) Any other responsibilities assigned by Head of Quality Your experience and qualifications M Pharm/ B Pharm/ M Sc  10 plus years relevant experience in Quality & Analytics Must have experience in QMS.
Reports To In process of validation 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.
We are committed to a diverse and inclusive workplace for all.
If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process.
All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.