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, batch records 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 of QMS documents and ensuring that the supply is 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 of deviations/OOS/OOT
Management of Global/Regional Projects
Life cycle management of Change control system
Preparation of Standard Operating Procedure
Training Management
Document Management
Batch record review.
Your experience and qualifications
M.Sc (Sciences) or B.Pharm / M.Pharm
Minimum 10 years of experience in Quality Assurance in pharmaceutical industry
Knowledge of cGMP, Quality management Systems and the pharmaceutical manufacturing
Knowledge on Compliance Standards and Regulation as applicable to the market