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 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.
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
Reports To Assoc Director Quality Assurance
Teva’s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
