Teva Mgr Quality Function 

India, Karnataka, Bengaluru 

275199588

• 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

• 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.
  

• 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.
  

Associate Director, Quality Assurance

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