The opportunity
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.
Quality Management System – Change control, Deviation and complaints.
KPI Metrics and improvement actions for QMS system.
How you’ll spend your day
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
Review of Change controls/Batch Records/Investigations: Ensure change controls are reviewed as per regulatory requirements in timely manner. Review of batch manufacturing and packing records along with associated validations and periodic batch record reviews. Review of investigations pertaining to deviations and complaints as per requirements.
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.
Any other duties as assigned by the supervisor