Senior Professional, R&D Quality Assurance
Zagreb, Croatia, 10000
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.
How you’ll spend your day
- Primarily supporting R&D activities in Zagreb, with additional responsibility to support other Teva R&D units as part of Quality Shared Services
- Opportunity to learn about and be involved in other drug delivery methods through shared services, such as respiratory or implants
- Ensure that current Good Manufacturing Practices, Teva Global Policies and Standards and relevant Regulatory Authority requirements are met
- Understanding of Teva pharmaceutical development process (including the QMS), and contributing to Quality related decisions that affect product development
- Reviewing and approving documentation generated in support of new products and processes to ensure compliance with regulatory requirements
- Review of starting materials documentation as well as finished product documentation
- Providing Quality review of CMC regulatory submissions when required
- Support Vendor Approval Program (review of vendor documentation, QTAs, etc.)
- Investigating OOS results and defining corrective and preventative actions
- Evaluating changes related to development processes
- Train and maintain proficiency with computerized systems (Glorya, TrackWise, Veeva, Studium, IT system etc.).
Your experience and qualifications
Qualifications:
- Minimum degree in Pharmacy, Science, Engineering or similar
- Minimum of 2 year in a Quality Assurance/ Analytical control/ other related experience in manufacturing or R&D environment within the pharmaceutical industry
- Experience in sterile operations to EU and FDA standards is desirable
Knowledge:
- Knowledge of ICH, ISO, US, and EU guidelines
- Understanding of GMP requirements in relation to manufacture and packaging
- Understanding of Quality Management Systems
- Understanding of the analytical methods and knowledge of product development and manufacturing is a plus
Skills:
- Good communication skills
- Good interpersonal and communication skills as well as organizational skills
- Ability to communicate complex issues to affected departments and solve problems
- Orientation to achieving results and attention to detail
- Proficiency in MS Office; knowledge of SAP, Track Wise® and EDMS is desirable
- Very good in written and spoken English
Already Working @TEVA?
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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.