General Electric Qualified Person in Eindhoven, Netherlands
Job Description Summary
As QP you are responsible for batch certification. You ensure the batch is produced and checked in accordance with legal requirements, quality guidelines, procedures and registered files. You will work in the dynamic environment of radiopharmaceuticals.
GE Healthcare is a leading global medical technology and digital solutions innovator with over 100 years of healthcare industry experience and around 50,000 employees globally. We enable clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by our Edison intelligence platform. We operate at the center of an ecosystem working toward precision health - digitizing healthcare, helping drive productivity and improving outcomes for patients, providers, health systems and researchers around the world.
Our Pharmaceutical Diagnostics (PDx) business is the number one global supplier of contrast media and molecular imaging agents used to enhance medical imaging exams. Used throughout all major disease area diagnostic and treatment pathways, PDx products support three patients every second around the world.
In Eindhoven we produce radio pharmaceutical products and distribute them to hospitals worldwide.
Review of batch documentation and manufacturing process to support the decision to release the product in accordance with all licensing and GMP requirements
Reviewing and approving deviations, CAPA, Change Control, Complaints and procedures
Represent QA in various (development and improvement) projects and advise on the adequacy of validation of facilities, equipment and new products / processes, including design strategies
Supervising and coordinating inspections by external (regulatory) authorities (IGJ), as well as supporting the QA audit function to ensure GMP compliance
Establish and maintain quality management systems
Maintaining current knowledge of pharmaceutical legislation and best practices and implementation thereof.
Qualifications / Requirements
Academic degree in Pharmacy, Chemistry, Pharmaceutical Chemistry & Technology, Biology or equivalent
Relevant experience as QP in the GMP production and QA environment within a pharmaceutical company
Knowledge of sterile product manufacturing and associated QA requirements, including aseptic preparation
Fluent Dutch and excellent Englishis a must
Able to work under pressure and make good, timely decisions.
Energetic team player with excellent communication and social skills
Promote a culture of continuous improvement
Ability to communicate effectively with all levels of personnel within all cross functional departments and regulatory inspectors
Living in the Eindhoven region.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Relocation Assistance Provided: No