Quality Assurance Analyst, Qualification Facility & Utility
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….
ClinChoice, is searching for a Quality Assurance Analyst, Qualification Facility & Utility to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines, where you will work at Geel office, until 31 December 2026.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.
Scope of the role:
In this role you will support the QA Engineering department in assuring that all Qualification related regulatory and procedural requirements are fulfilled during the complete life cycle (concept, project, operational and retirement phase) for Geel Facility and Utility systems.
Main Job Tasks and Responsibilities:
- Review and approve qualification documents & quality records such as SOPs, user requirements, impact/risks analysis’s, Test Plans, test scripts, change controls, CAPA’s etc. in order to maintain compliance to regulations, guidelines, and Company policies and standards.
- Be part of engineering teams and interact with other groups for the introduction of new/upgraded systems and processes. To give advice and support for the preparation of qualification related activities and guard the cGMP aspects.
- Address and follow-up of deviations occurred during execution of qualification activities.
- Communicate status (quality & compliance, planning) towards Company QA Qualification team members.
Education and Experience:
- University/Bachelor’s Degree or Equivalent.
- Experience in chemical and/or pharmaceutical industry with respect to qualification of equipment.
- Knowledge of cGMP regulations and guidelines.
- Capacity to ‘translate’ technical information into information that can be understood at every level of the organization.
- Being able to correctly estimate the urgency, criticality and impact of decisions related to the function.
- Ability to multi-task and work on a variety of projects at one time.
- Ability to work independently and work in cross-functional team environment.
- Good communication skills.
- Fluent in English and Dutch (spoken and written).
- Facility and Utility systems used within pharmaceutical or chemical industry.
- Problem report, change request systems. (f.e. Trackwise, Comet).
- Document Management systems (f.e. TruVault).
- Test tools (f.e. Kneat).
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
Key words: Quality Assurance Analyst, Qualification Facility & Utility, Quality Management System, CAPA, GMP, Regulatory Compliance, Technical Documentation, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated.
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