Job 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.
The opportunity
- The jobholder acts as a member of Teva External Manufacturing and Supply Operations (EMSO).
- Jobholder closely interacts with the Team, the CMO Manager and QRM and if required other departments such as Operations, Procurement, Supply Chain, MS&T, and Regulatory Affairs and provides complete support from quality perspective.
- The position is to review the QMS documents like change controls, deviations, OOS/OOT associated with formulations that include various dosage forms of products supplied to EMSO. The market is primarily for US, EU, UK and Canada.
- The jobholder will be responsible for review and approval of QMS documents and ensure that the product transfers are completed as per target timelines and Supplies are not interrupted due to the delay and provides timely updates on the status of the QMS documents
How you’ll spend your day
- Responsible to follow the Quality Management System of EMSO organization, which is relevant to the job function.
- Review and approval of deviations/OOS/OOT.
- Review of method validation/verifications and method transfer reports.
- CAPA Management.
- Management of Global/Regional Projects.
- Life cycle management of Change control system.
- Preparation of Standard Operating Procedure.
- Training Management.
- Document Management.
- Batch record review.
- Evaluation of Elemental Impurity Risk assessments, Nitrosamines risk assessments shared by CMO for adequacy and ensures that the assessment of the same is included whenever changes are made.
Your experience and qualifications
- M.Sc (Sciences) or B.Pharm / M.Pharm
- 12 – 15 years of experience in Quality Assurance. Candidate with experience in both OSD and Sterile industry would be preferred.
- Knowledge of cGMP, Quality management Systems and the pharmaceutical manufacturing.
- Knowledge on Compliance Standards and Regulation as applicable to the market.
- Hands on experience in handling lab instruments in QC /R&D labs.
Reports To Associate Director, Quality Assurance
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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. 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.
