Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

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 monitoring Quality Management System 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.
• Quality Management System
• Deviation Management
• Analytical & Manufacturing Investigations review/Approval.
• Escalation of Critical issues to management
• KPI Monitoring and improvement actions for QMS system.

How you’ll spend your day

• 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 and approval of Analytical and Manufacturing investigations received from CMOs as per internal timelines and requirements.
• KPI Metrics management for EMSO Quality and ensure no overdue Deviations.
• Responsible for Audit readiness activities at EMSO APAC and management of audits.
• 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.S. Sciences.
• Minimum 10-15 years of experience in pharmaceutical industry
• Knowledge of cGMP, Quality management Systems and the pharmaceutical manufacturing, supply chain environment
• Knowledge on Compliance Standards and Regulation as applicable to the market.
• Handling Manufacturing and Analytical investigations
• Experience of handling Operational Quality, QA/QC exposure and External / Contract manufacturing sites.
• Knowledge and working experience with USFDA / EU and other competent authority approved sites.
• Problem Solving & Decision Making
• Communication - Negotiating / influencing skills.

Reports To

Assoc Dir Quality Assurance

Teva’s Equal Employment Opportunity Commitment