Senior Quality Assurance Manager
3 weeks ago
Quality Assurance Role
The position of Senior Quality Assurance Manager at Teva Pharmaceuticals involves acting as a member of the company's External Manufacturing and Supply Operations (EMSO). The jobholder is responsible for ensuring the compliance of EMSO Quality Systems with regulatory requirements and Teva Quality Management Standards.
Key responsibilities include ensuring timely decisions to the EMSO Supplier Relationship team (SRT) and Contract Manufacturing Organizations (CMOs) on all issues. The jobholder is also responsible for Quality Oversight of contract manufacturing sites at EMSO APAC.
Key Activities
- Responsible for following the Quality Management System of the EMSO organization, relevant to the 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
Job Responsibilities
- 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 meet 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.
Requirements
- 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
About Teva Pharmaceuticals
Teva Pharmaceuticals is a leading global pharmaceutical company dedicated to improving people's lives through the development and delivery of innovative medicines and services. We strive to be a trusted partner to our customers, patients, and employees, and to make a positive impact on the communities we serve.
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