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 Control Analyst to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines, where you will work HYBRID at Leiden, Netherlands, 1.0 FTE for a 1 year contract.

We are looking for a contractor to support our client as a Business System Owner automation within the Bioprocessing Services department to strengthen the team. Do you have a background in automation and have experience with MES, Delta-V, Scada or OSIsoft PI, we may need you.

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:

As the Business System Owner for automated production systems you are the link between operations and automation. You collaborate closely with both local and global stakeholders on your systems and you make sure the systems stay in qualified status by managing Access management, maintenance, data integrity, audit trail review, back-up and archival strategy.

The responsibilities & the impact YOU will have:

• You keep oversight on all activities and operation of your system.
• You make sure systems stay in a qualified state and in case of deviations, you handle these to stay in compliance.
• You are responsible for data management and data integrity activities on your systems.
• You are responsible to support projects, eg software updates or improvements, in a compliant way with minimal impact to production processes.
• You ensure a solid business continuity plan is available for your system.
• As Business System Owner you are responsible for your systems and data life cycle management on these systems.
• cGxP and EHS requirements are highly values in our department.

We would love to hear from YOU, if you have the following essential requirements:

• Relevant education in IT/Automation or specialized in this topic in a BSc. or MSc degree in science/biotechnology/chemistry.
• You have at least 2 years of relevant work experience and knowledge on Automation/CSV guidelines.
• You know about the high standards in pharma in cGxP and EHS.

We also would like to see the following Key Competencies

• You are enthusiastic, independent, innovative (be able to think outside the box) and stress resistant (be able to deal with pressure, fast changes).
• You can collaborate at different levels in the organization.
• You have great analytical skills and find it easy to find dependencies.
• You are quality minded and have a high service level.
• You take ownership of your work and have the ability to plan and structure this.

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 Control, Automation, CSV, Computer System Validation, cGxP.

#LI-PR1 #LI-HYBRID #CONTRACT

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