Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!
As the Quality Compliance Associate you will support the site's Quality Systems & Compliance team in maintaining quality at the department in accordance with Site SOP’s, Teva Global Standards, regulatory guidelines and cGXP compliance requirements.
You will manage high standards of quality at the department through continuously improving the effectiveness of the department quality processes and systems.
Prepare and support department policies and objectives in line with Teva and Site policies.
Coordinate and execute the implementation of Teva standards and procedures at the site.
Ensure the implementation of and compliance with national and international quality standards (cGXP) as well as Teva Global standards.
Organize the evaluation of vendors and approve and maintain their Qualification status, including Quality Technical Agreements.
Assure robust inspection preparation systems that include the organization of front and back office as well as the training of SME’s.
Support inspection preparation as well as support of front and back office during inspections.
Ensure permanent inspection readiness on the site.
Share best practices, challenges and lessons learned within the site across the Teva Quality organization in order to improve the performance of quality globally.
Monitor and adjust day-to-day performance and operations.
Uses analyses to identify root causes and determine CAPAs Recognizes when changes in product, process or regulations will require changes in tasks and plans accordingly.
University level (Pharmacy / Chemistry) or HBO+ with several years of experience in a quality position in the pharmaceutical industry.
Experience with pharmaceutical processes, techniques, and cGXP.
Familiar with process automation.
Ability to stay current with and apply in daily activities a strong working knowledge of cGXPs/regulatory guidance’s and data integrity to ensure full compliance.
Ability to ‘translate’ the local SOP’s to day-to-day activities in the review and approval of documents.
Knowledge of relevant regulatory guidance’s (within the scope of responsibilities).
Regulatory Agency/Industry guidance’s, Pharmacopeial Guidance’s and Requirements including local regulatory requirements.
Ability to collaborate with internal team to support a successful inspection and to provide timely and thorough responses to the regulatory authority.
Positive ‘can –do’ mindset
Fluent in Dutch (preferred) and English language (essential).
Teva will carry out appropriate verification and legally permitted vetting prior to the confirmation of any offer of employment. More information on this verification and vetting will be provided if you reach this stage of the application process.
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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.