GE HealthCare Qualified Person Trainee 

Netherlands 

419282152

Essential Responsibilities

• 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 (max 6 bullet points)

• 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.

Desired characteristics (3-6 bullet points)

• 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.

Total Rewards

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.