Engineering Management & Business Others Medical and Healthcare Other Science and Tech
Postcode 2031 in Haarlem
Senior Quality Systems Associate
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!
The Quality Systems Associate supports the site's Quality Systems & Compliance team in establishing and maintaining quality at the department in accordance with Site SOP’s, Teva Global Standards, regulatory guidelines and cGXP compliance requirements.
Maintain high standards of quality at the department through managing and continuously improving the effectiveness of the department quality processes and systems
Consistently measure, monitor and report site quality key performance indicators
Support in identifying, developing, and retain qualified people to implement the quality processes
Participate in team’s that have the technical expertise, personal skills and interpersonal skills needed to influence site Operations and is conversant in application of regulations
Maintain a culture of enhancing quality throughout the entire site operation, ensure an effective internal communications structure with relevant departments
Risk based quality decision making. Review and provide options to meet business needs without compromising quality and compliance
Share best practices, challenges and lessons learned at the site and on SME topics also across the Teva Quality organization in order to improve the performance of quality globally
Ensure product transfers across sites also include the transfer of quality information (knowledge, risks, documentation for manufacture and control processes, validations, Product Quality Reviews)
Timely management of investigations, CAPAs, coordination of Regulatory commitment, GRAs, Audits, standard implementation to ensure sustainable compliance
Degree in science (Pharmacy / Chemistry) or HBO with several years of experience in a quality position in the pharmaceutical industry
Experience with pharmaceutical processes, techniques, cGXP and process automation
Ability to communicate technical, regulatory and business issues in a clear (and when necessary, in a non-technical) way
Ability to understand and define a problem clearly
Clear and timely Decision-making skills
An eye for continuous process improvement/ efficiency
Prefererably, fluency in Dutch & English written and spoken.
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