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 Validation Supervisor to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines. This role supports the QA Engineering department. You will be required to work on-site daily in Geel, Belgium 1.0 FTE, 1 year contract.
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:
- Review and approve CSV documents & CSV records such as SOPs, user requirements, impact/risks analysis’s, test plans, test scripts, change controls, CAPA’s etc…) in order to maintain compliance to regulations, guidelines, and policies and standards.
- Be part of engineering teams and interact with other groups for the introduction of new/upgraded systems and processes. To give advice and support for the preparation of CSV related activities and guard the cGMP aspects.
- Address and follow-up of deviations occurred during execution of CSV activities.
- Communicate status (quality & compliance, planning,…) towards QA Qualification team members.
Education and Experience:
- Bachelor’s degree or higher in Biochemistry, Biology, Pharmaceutical degree or relevant education.
- Review and approve CSV documents & CSV records such as SOPs, user requirements, impact/risks analysis’s, test plans, test scripts, change controls, CAPA’s etc…) in order to maintain compliance to regulations, guidelines, and J&J policies and standards.
- Be part of engineering teams and interact with other groups for the introduction of new/upgraded systems and processes. To give advice and support for the preparation of CSV related activities and guard the cGMP aspects.
- Address and follow-up of deviations occurred during execution of CSV activities.
- Communicate status (quality compliance, planning,…) towards QA Qualification team members.
- Experience in chemical and/or pharmaceutical industry with respect to CSV of manufacturing automation systems.
- Knowledge of cGMP regulations and guidelines.
- Capacity to ‘translate’ technical information into information that can be understood at every level of the organization.
- Being able to correctly estimate the urgency, criticality and impact of decisions related to the function.
- Ability to multi-task and work on a variety of projects at one time.
- Ability to work independently and work in cross-functional team environment.
- Fluent in English & Dutch (written and spoken)
- Manufacturing automation systems used within pharmaceutical or chemical industry (f.e. DeltaV).
- Document Management systems (f.e. TruVault)
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.
Keywords: Validation Manager, CSV, API, Validation Document, Contract Research Organisation, CRO, Quality Assurance, Computer System Validation, CAPA
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