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수평: Mid-Senior level
직업 종류: Contract
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작업 내용
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 to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines, where you will work in a hybrid-based model in Beerse, 0.5 FTE for 6 months.
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.
Main Job Tasks and Responsibilities:
- Validation Planning: Develop and execute validation strategies, ensuring compliance with industry standards and company policies.
- Documentation: Create and maintain comprehensive validation documentation, including validation plans, protocols, and reports in accordance with Software Development Lifecycle (SDLC) SOP and other relevant SOPs.
- Risk Assessment: Perform risk assessments to identify potential validation issues and develop mitigation strategies.
- Testing: Lead and participate in the execution of Computer Systems Validation (CSV) testing activities, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
- Collaboration: Work closely with cross-functional teams, including IT, quality assurance, and regulatory affairs, to ensure all validation efforts meet project timelines and specifications.
- Compliance: Ensure adherence to regulatory requirements (e.g., FDA, ISO) and internal compliance standards throughout the validation lifecycle.
- Training: Provide guidance and training to team members on Computer Systems Validation (CSV) best practices and procedural compliance.
- Bachelor’s degree or higher in sciences (e.g., chemistry, biology, pharmacy, information technology, engineering).
- Minimum of 3-5 years of experience in CSV validation, preferably in a regulated environment.
- Industry Knowledge: Prior experience working within the healthcare or pharmaceutical sectors.
- SDLC Understanding: Comprehensive knowledge of the Software Development Life Cycle (SDLC) and its application within validation processes.
- Documentation Skills: Proven ability to create detailed, compliant documentation (SOPs, validation protocols, reports).
- Analytical Skills: Strong analytical and problem-solving skills to identify issues and implement corrective actions.
- Fluent in English and Dutch (spoken and written).
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, Quality Assurance, Validation Planning, Risk Assessment, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated.
#CONTRACT
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마감 시간: 09-01-2026
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