Teva Quality Analyst II 

Malaysia, Penang, George Town 

492906741

Jobholder closely interacts with the Team Leader and the QRM’s 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 batch records, change controls, deviations, LIR, APR associated with formulations that include various dosage forms of products supplied to EMSO. The market is primarily for US, EU 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.

To manage the EMSO Quality system requirements in accordance with Teva quality standards and in compliance with the regulatory requirements.

This activity has the following aspects –

• Batch record review and disposition in global system like SAP etc.
• Responsible to follow the Quality Management System of EMSO organisation, which is relevant to the job function
• CAPA management
• Life cycle management of Change control system
• Review of deviations/LIRs
• Review of APRs
• Preparation of Standard Operating Procedure
• Training Management
• Document Management

Qualification: M/Pharm/ Pharma/ M.Sc. Chemistry

Experience; 6+ years