Quality Assurance Specialist

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 Specialist to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines, where you will work on site for four days in Groningen, 1.0 FTE until 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.  

 

Main Job Tasks and Responsibilities:

• Administers the change control program and manages local procedures and specifications in the document control system.
• Leads efforts to comply with company policies, procedures, and quality standards; as well as safety and environmental regulations.
• Writes and assists others in writing new or updated operating procedures.
• Generates, identifies, and suggests improvements in significant performance trends. Reports them to management and appropriate cross functional teams.
• Manages non-conformity.
• Advises, reviews, and approves changes in products/processes or systems, in line with the applicable procedures. Approves all QMS related procedures and work instructions.
• Ensures continuous improvement of the focus area in response to regulatory developments, trends, deviations or other data-driven inputs.
• Investigates and resolves Corrective and Preventive actions (CAPAs).
• Manages the quality system.

Support engineering projects to ensure quality assurance within implementation of new processes and equipment:

• Provide overall quality assurance input and guidance in engineering projects.
• Assisting in the creation and approval of equipment and process validation documentation
• Drawing up validation plans and reports.

Support R&D function to ensure quality assurance within product and process development projects by:

• Performing risk analyses
• Drawing up the risk management plan and report.
• Drawing up validation plans and reports.
• Auditing the Design History File.
• Participate during Design Reviews.

Support Quality Operations by:

• Addressing non-conformities within production and taking care of internal escalations
• Guiding planned deviations from the production process.
• Advising, reviewing and (approving) changes in production processes, in line with the applicable procedures.
• Analyzing data on rejects within the production process for continuous improvement and reducing or eliminating sources of variation within the production process.

 

Education and Experience:

• University/Bachelor’s Degree or Equivalent Work Experience: 4-6 years of relevant work experience, preferably in the pharmaceutical or medical-device industry.
• Medtech/pharma experience, validation experience, Senior QA engineer.
• Knowledge of GMP, MDD/MDR, QSR CFR 820, ISO 13485, ISO 14971.
• Knowledge of quality assurance systems (QMS).
• Knowledge of relevant work rules and procedures.
• Knowledge of MS Office.
• Knowledge of validation of technical systems and processes.
• Knowledge of statistics and quality improvement techniques.
• Attitude/ Skills - Communicative - Flexible and accurate - Able to function both independently and in a team.
• Proficiency in written and oral English, with a desirable command of Dutch.

 

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 Specialist, Quality Assurance, Quality Assurance System, CAPA, GMP, ISO 13485, ISO 14971, Ms Office, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated.

 

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