Quality Assurance Validation Analyst II

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 Validation Analyst to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines. You will be required to work on-site daily in Geel, Belgium 1.0 FTE, 1 year assignment through August 31, 2026. The Validation Analyst, as part of the MSAT team, specializes in cleaning validation, overseeing documentation such as protocols, reports, and studies. Expertise experience is required in cleaning validation processes, to ensure the following:

• Timely creation and revision of validation documentation
• Prioritization of projects by assessing proposed changes
• Support for audits and regulatory readiness
• Smooth integration of new products and equipment into the validation program

Key competencies include technical expertise, project prioritization, documentation management, and audit preparedness.

Main Job Tasks And Responsibilities:

• Strong expertise on API manufacturing processes.
• Strong knowledge in validation.
• Knowledge of statistics.
• Project management, organizing, planning and coordination skills.
• Strong mind-set and knowledge of Quality & Compliance/ regulatory requirements (GMP) in particular around cleaning validation.
• Adheres to applicable cGxP's, procedures and management systems.
• Reports incidents and deviations.
• Proposes solutions to improve compliance with cGMP's.
• Reporting of (near) accidents, incidents, deviations.

Education And Experience:

• Master's Degree in (Bio)Sciences or Life Sciences.
• Ability to manage complexity, strict deadlines and change.
• Ability to interact at different levels of the organization.
• Ability to work under pressure, handle conflicting interests, having a good sense of prioritization of assigned tasks goals and manage time accordingly.
• Customer and business focus.
• Informs the manager and can call on the manager for consultation, in case of problems with stakeholders, fundamental problems concerning (technical) feasibility, etc.
• Strong skills in communication and a result driven personality.
• Languages: Dutch, English (written and spoken)

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, Quality Assurance, Global Information Systems, GMP, Computer System Validation, Quality Control, Computer System Validation Documentation, eLIMS, truVAULT, COMET, PRX, CRB, SAP, PASx, Minitab, CPV Automation

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