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.
Your experience and qualifications
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