QA specialist

Job Description SummaryPurpose
The QA Specialist is responsible for the development and maintenance of Quality Management System, reporting and operating mechanisms to help drive the site quality objectives.
Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). Impacts quality of own work and the work of others on the team. Focused on execution of standard enabling activities/provision of advice subject to policy and work routines within an enabling discipline. There may be some latitude to rearrange the sequence to complete task/duties based on changing situations.

Job Description

“GE HealthCare is een toonaangevende wereldwijde innovator op het gebied van medische technologie en digitale oplossingen. Ons doel is om een wereld te creëren waar gezondheidszorg geen grenzen kent. Laat je ambitie spreken, transformeer ideeën in baanbrekende realiteiten, en word onderdeel van een organisatie waar elke stem ertoe doet en elk verschil bijdraagt aan een gezondere wereld.”

Pharmaceutical Diagnostics (PDx) is de nummer één wereldwijde leverancier van contrastmedia en moleculaire imaging agents die worden gebruikt om medisch beeldvormingsonderzoek te verbeteren. PDx-producten worden gebruikt in alle belangrijke diagnostische en behandelingstrajecten en helpen zo 3 patiënten per seconde over de hele wereld.

Essential responsibilities

Developing and maintaining the Quality Management System, reviewing and approving quality related documentation and providing QA support in site projects and improvement initiatives. This position includes execution of QA activities, such as handling of deviations, change controls, complaints, providing GMP related training, review and approval of (validation) documentation and document management.

Description responsibilities

• Developing and maintaining the Quality Management System, including, but not limited to:
  • Deviation and CAPA
  • Complaint handling
  • Change Control
  • Auditing
  • Training
  • Vendor management
  • Batch release
  • Metrics and trending
  • Documentation
• Supporting the preparation and execution of Quality Management Reviews at the site.
• Reviewing of production documentation and assisting with batch release procedures, including raw material release.
• Liaising with Operations personnel to ensure regulatory and quality requirements are met during routine operations.
• Performing root cause investigations (for deviations/complaints) and defining appropriate corrective and preventive actions.
• Reviewing and approving deviations, CAPA, Change Control, Complaint and maintenance activities.
• Participating in audits and spot checks, including follow up activities.
• Responding to routine quality related queries from other departments.
• Monitoring and aiding the implementation of continuous improvements and process changes to ensure that these are implemented in compliance with GMP.
• Training of personnel.
• Representing QA in cross functional team meetings / projects.
• Conducting QA activities including revision of SOPs, SAP QA work and the issuance/review and approval of (validation) protocols and reports.
• Comply with the Environment, Health & Safety (EHS) Policies and applicable laws and regulations.

Knowledge and experience

• Minimum Bachelor degree in relevant field (e.g. pharmacy, chemistry, biology, life sciences).
• 1 year experience in pharmaceutical or medical device industry.
• Relevant experience in GMP production/ QA environment within a pharmaceutical company.
• Familiar with cGMP and sterile manufacturing.
• Proficient with MS Office (Word, Excel, Powerpoint).
• Ability to communicate effectively in Dutch and English (both written and oral).

Competencies

• Attentive to detail.
• Quality focused.
• Results oriented.
• Responsive to customer needs.
• Ability to identify root causes of problems, and creatively problem solve to gain resolution.
• Ability to work independently in fast-paced environment with little supervision.
• Ability to adapt to constant change and influence positive change effectively.

Ons totale beloningspakket is ontworpen om je de ruimte en flexibiliteit te bieden die nodig zijn om jouw ideeën om te zetten in baanbrekende veranderingen. Ons salaris en onze secundaire arbeidsvoorwaarden zijn alles wat je mag verwachten van een organisatie met wereldwijde kracht en schaal en er zijn volop carrieremogelijkheden in een bedrijfscultuur die zorg, samenwerking en ondersteuning bevordert.

We verwachten van alle medewerkers dat ze onze gedragsregels naleven: handelen met bescheidenheid en vertrouwen opbouwen; leiden met transparantie; werken met focus en verantwoordelijkheid stimuleren- altijd met onverminderde integriteit.

GE HealthCare is een Equal Opportunity Employer waar inclusiviteit belangrijk is. In ons aannamebeleid spelen ras, huidskleur, religie, nationale of etnische afkomst, geslacht, seksuele geaardheid, genderidentiteit, leeftijd of handicap geen rol.

Additional Information