Data Integrity Specialist, Quality Assurance (Computer System Validation)

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 Data Integrity Specialist, Quality Assurance Computer Systems Validation (CSV) to work with one of our partner biopharmaceutical companies. This is a full-time (1 FTE) temporary employment position to the end of 2026 initially.

The Data Integrity Specialist will focus on Innovative Medicine Supply Chain systems, primarily from our client in Beerse. Hybrid working with 2 days working from home per week is permitted.   

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:

 

• Cooperate with multifunctional teams to assess local systems and equipment.
• Define risks and vulnerabilities for the local systems and equipment.
• Provide Data Integrity guidance and support towards local Subject Matter Experts.
• Define remediation activities and create Data Integrity plans.
• Act as local Process Owner for Data Integrity.
• Support the Small Molecules Data Integrity Community of Practice.
• Organize and lead sessions with Data Integrity representatives of multiple sites.
• Assist site Subject Matter Experts with the assessment process of all site specific systems and equipment.
• Assist Site Subject Matter Experts with Data Flow Mapping and Risk Assessments.
• Organize, manage and perform SM Platform based Data Flow Mapping and Risk Assessments.
• Maintain a current knowledge of international laws, guidelines and new evolutions related to Computer System Validation through courses, conferences, seminars, internal and external benchmarking and literature studies. Implement this knowledge to maintain and improve Computer System Validation at sponsor.
• Prepare for audits and inspections by regulatory agencies, customers and internal compliance team.
• Be an Subject Matter Expert for Data Integrity matters during audits and inspections.
• Cooperate with engineering, IT and other teams for the Data Integrity compliance during introduction of new systems, equipment and processes.
• Give advice and support for the preparation of Computer System Validation related activities and guard the cGMP aspects in new projects. Be a member of multi-functional teams to realize cross-departmental objectives.

 

Education, Experience and Skills:

·        Master scientific degree or equivalent experience.

·        3 years’ experience in the pharmaceutical industry.

·        Knowledge of cGMP/CSV compliance (21 CFR Parts 11, 210, 211; Eudralex 4, EU Directive 2003/94/EC, EU Directive 2017/1572 and annex 11; GAMP, Data Integrity Guidelines).

·        Strong ownership and Quality mindset. You are able to deliver on commitment timelines.

·        Ability to make risk-based decisions. Understands the business implications regarding quality positions and decisions.

·        Experience with Data Integrity remediation activities.

·        Experience with Computerized System Validation.

·        Fluent in verbal and written communication in English and Dutch and are able to connect with diverse partners.

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: Data Integrity Specialist, Computer Systems Validation, DIS, CSV, Quality Assurance, Temporary

 

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