Job Description SummaryAs a QP you are ultimately responsible for batch certification. You ensure that the batch is produced and checked in accordance with legal requirements, quality guidelines, procedures and registered files. You also advise on quality improvements and quality issues. In addition, you will support and perform various QA activities to maintain the QMS. You work in the fast-responding and challenging world 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.
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.
At GE Healthcare in Eindhoven we produce radiopharmaceutical products, which are distributed 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;
- Has actively worked as a QP in accordance with EU legislation 2001/83 / EC, for at least 2-5 years;
- Relevant experience in the GMP production and QA environment within a pharmaceutical company;
- Knowledge of sterile product manufacturing and associated QA requirements, including aseptic preparation;
- Proficient comprehension and understanding of the Dutch language is a must.
- Excellent oral and written communication skills in English;
- Able to work under pressure and make good, timely decisions.
- Energetic team player with excellent communication and social skills;
- Enthusiastic and committed to success and continuous improvement;
- Be able to interact well with and be credible to employees at all levels, from shop floor to site director 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.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
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, age, disability, protected veteran status or other characteristics protected by law. We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
Relocation Assistance Provided: No