AMVETS Jobs

Job Description Summary

As CQV Quality Assurance Specialist, your provide Quality and Compliance oversight in the design, building, installation and qualification of new facilities, utilities, equipment and processes. You will be the Quality SME (Subject Matter Expert) in this area for the (larger) site projects and provide Quality support to meet the regulatory and GMP requirements. This is an onsite role at our production site in Eindhoven. It is required to communicate effectively in both Dutch and English.

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.

GE HealthCare Pharmaceutical Diagnostics (PDx) 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.

GE HealthCare in Eindhoven produces and distributes pharmaceutical products for hospitals worldwide. As part of the Pharmaceutical Diagnostics (PDx) business of GE HealthCare, we support the PDx vision of being the best-in-class supply chain delivering the right dose to the right patient at the right time.

Key responsibilities

• Supporting site (cross-functional) projects as Quality SME for the design, qualification and validation of new facilities, utilities, equipment and processes;

• Providing guidance and process support for engineering and validation teams in accordance with applicable GMP Regulations and procedures;

• Leading and participating in risk assessments (e.g. FMEA) associated with projects;

• Reviewing and approving project /validation documentation (e.g. URS, CQV protocols and reports, FAT/SAT, Risk Assessments) and SOP’s;

• Leveraging knowledge and expertise into own and other departments;

• Liaising with Operations and other Quality personnel to ensure regulatory and quality requirements are met during routine operations.

• Monitoring and aiding the implementation of continuous improvements and process changes to ensure that these are implemented in compliance with GMP;

• As part of the QA team participate in maintaining the QMS;

• Comply with the Environment, Health & Safety (EHS) Policies and applicable laws and regulations.

Knowledge and experience

• Significant experience in a QA/Validation related position within the pharmaceutical or life-sciences industry;

• Strong technical knowledge and experience in pharmaceutical environment, preferably in aseptic processing (sterile manufacturing), sterilization, cleanroom facilities, utilities and process equipment;

• Knowledge and understanding of cGMP regulations with respect to the validation, production and testing of pharmaceutical products (Eudralex Annex 1, Annex 11, 21 CFR Part 11, GAMP 5, Annex 15, ISPE);

• Strong track record of identifying, escalating and correcting compliance issues and implementing process improvements;

• Minimum bachelor’s degree in relevant field (e.g. pharmacy, chemistry, biology, life sciences). A Master’s degree is a plus.

• Proficient with MS Office (Word, Excel, Powerpoint);

• Ability to communicate effectively in Dutch and English (both written and oral).

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

Inclusion & 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 age, disability, protected veteran status or other characteristics protected by law.

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Additional Information

Relocation Assistance Provided: No