Quality Assurance Specialist
OkloSalary not specified
Full Time
Junior (1 to 2 years)
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Healthcare, Pharmaceuticals, Medical Imaging, DiagnosticsIndustries
Requirements
- Universitaire opleiding in Farmacie, Chemie, Farmaceutische Chemie & Technologie, Biologie of gelijkwaardig
- Relevante werkervaring als QP in overeenstemming met EU-wetgeving 2001/83/EG
- Relevante werkervaring in een GMP-productie en QA-omgeving binnen een farmaceutisch bedrijf
- Kennis van productie van steriele producten en bijbehorende QA-vereisten, inclusief aseptische bereiding
- Goede beheersing en begrip van de Nederlandse taal
- Uitstekende mondelinge en schriftelijke communicatievaardigheden in het Engels
- In staat om onder druk te werken en goede, tijdige beslissingen te nemen
- Goede communicatieve vaardigheden; in staat om goed te communiceren met medewerkers op alle niveaus
- Enthousiasme en toewijding aan succes en continue verbetering
- Woonachtig in de regio Eindhoven (reistijd enkele reis is minder dan 1 uur)
Responsibilities
- Beoordeling van batchdocumentatie en het productieproces ter ondersteuning van de beslissing om het product vrij te geven in overeenstemming met alle vergunnings- en GMP-vereisten
- Beoordelen en goedkeuren van afwijkingen, CAPA’s, Change Controls, klachten en procedures
- Vertegenwoordigen van QA in diverse (ontwikkelings- en verbeterings)projecten en adviseren over de geschiktheid van validatie van faciliteiten, apparatuur en nieuwe producten/processen, inclusief ontwerpstrategieën
- Toezicht houden op en coördineren van inspecties door externe (regelgevende) autoriteiten (IGJ), evenals ondersteuning van de QA-auditfunctie om GMP-naleving te waarborgen
- Opzetten en onderhouden van kwaliteitsmanagementsystemen
- Actuele kennis van farmaceutische wetgeving en best practices behouden en implementeren
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What is the salary for the Qualified Person role?
This information is not specified in the job description.
Is this a remote position or does it require on-site work?
This information is not specified in the job description.
What qualifications and skills are required for this role?
Candidates need a university degree in Pharmacy, Chemistry, Pharmaceutical Chemistry & Technology, Biology or equivalent, relevant experience as QP per EU legislation 2001/83/EG, experience in GMP production and QA in pharmaceuticals, knowledge of sterile product production and aseptic preparation, proficiency in Dutch, and excellent English communication skills.
What is the work environment like at GE HealthCare PDx Eindhoven?
The role is in the fast-paced and challenging world of radiopharmaceuticals, producing just-in-time products at the campus of Eindhoven University of Technology, within a leading global innovator in medical technology.
What makes a strong candidate for the Qualified Person position?
A strong candidate has QP experience compliant with EU legislation, GMP and QA background in pharmaceuticals, knowledge of sterile and aseptic production, fluency in Dutch, and excellent English communication skills, plus the ability to work under pressure.
GE Healthcare
Healthcare technology and data analytics provider
About GE Healthcare
GE Healthcare provides a range of healthcare technologies and services aimed at improving patient care. Its main products include imaging systems, mobile diagnostic devices, patient monitoring solutions, and advanced software for data analysis. These products help medical professionals make informed decisions and enhance the efficiency of healthcare delivery. Unlike many competitors, GE Healthcare invests significantly in research and development, allocating $1 billion each year to innovate and enhance its offerings. The company’s goal is to support healthcare providers in delivering better patient outcomes, as evidenced by its technology supporting over 300,000 patients daily and managing 2 billion patient scans each year.
Chicago, IllinoisHeadquarters
1892Year Founded
N/ACompany Stage
Data & Analytics, HealthcareIndustries
10,001+Employees
Risks
Emerging AR technologies increase competition in medical imaging.
Regulatory challenges may delay AI application expansions in healthcare.
Dependence on clinical trial success for new product market positioning.
Differentiation
GE Healthcare invests $1 billion annually in R&D for product innovation.
The company supports over 300,000 patients daily with its healthcare technologies.
GE Healthcare's AIR Recon DL offers 3D motion-insensitive imaging for enhanced MRI quality.
Upsides
Acquisition of Caption Health expands AI-powered ultrasound capabilities.
Successful Phase III trial of [18F]flurpiridaz enhances coronary artery disease detection.
Collaboration with Wayra accelerates digital health innovation in EMEA.
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