GE HealthCare CQV Quality Assurance Specialist 

Netherlands 

248199079

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.

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).

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