Teva Manager Quality Function 

Malaysia, Penang, George Town 

997539792

The jobholder acts as a member of Teva External Manufacturing and Supply Operations (EMSO). The jobholder ensures compliance of the EMSO Quality Systems with Regulatory requirements and Teva Quality Management Standards.

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 –

• Responsible to follow the Quality Management System of EMSO organization, which is relevant to job function.
• External/Contract Manufacturing Sites handling
• Escalation of Critical issues to management
• Quality Management System – Deviation, complaints and Change control
• KPI Metrics and improvement actions for QMS system

• External/Contract Manufacturing: Responsible for handling/oversight on contract manufacturing sites and ensuring quality compliance.
• Quality System Management for EMSO: Ensure Quality management system is in place for EMSO APAC through implementation and maintenance of SOPs related to the various job functions and compliance to the SOPs.
• Sterility Assurance/CCS: Review/Ensure Sterility Assurance and Contamination Control Strategy plan in contract manufacturing sites. Review of risk assessment and approval.
• CFT Co-ordination: Co-ordinate internally within EMSO and with other regions to meet the business requirements and escalations, if any
• KPI Metrics: Ensure KPI Metrics met the requirements for EMSO Quality and ensure no overdue QMS elements.
• To review and approve Complaint investigations and Change controls.
• Any other duties as assigned by the supervisor.

• B. Pharm, / M. Pharm / M.Sc. (Science), B.Sc. Sciences
• Minimum 10-15 years of experience in pharmaceutical industry (Sterile).
• Experience of handling Operational Quality, QA/QC exposure and External / Contract manufacturing sites.
• Knowledge on Sterility Assurance and Contamination Control Strategy
• Knowledge of cGMP, Quality management Systems and the pharmaceutical manufacturing, supply chain environment.
• Knowledge on Compliance Standards and Regulations as applicable to the market.
• Knowledge on Manufacturing and Analytical investigations
• Knowledge and working experience with USFDA / EU and other competent authority approved sites
• Good communication skills – Verbal & written,
• Strong negotiating / influencing skills to get the activities completed as per Teva expectations

Assoc Director Quality Assurance