Easter Seals Jobs

Job Description Summary

As 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.

Job Description

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

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.

Inclusion and Diversity

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.

Behaviors

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.

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.

Additional Information

Relocation Assistance Provided: No