The opportunity
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.
Jobholder is responsible to ensure timely decisions to Teva EMSO Supplier Relationship team (SRT) and CMOs on all issues. Jobholder is responsible for Quality Oversight of contract manufacturing sites at EMSO APAC.
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
How you’ll spend your day
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.