QA Validation Engineer (Lab)

Ver: 105

Dia de atualização: 16-11-2025

Localização: Geel Antwerp

Categoria: Alta tecnologia IT - Software Segurança de qualidade / Controle de qualidade

Indústria: Staffing Recruiting Pharmaceutical Manufacturing

Posição: Mid-Senior level

Tipo de empregos: Full-time

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Conteúdo do emprego

Responsibilities

Development, implementation and execution of URS, SIA, DQ, IQ, OQ, PQ, RV and TM activities for mainly small scale equipment. Develops, implements and executes validation studies for cGMP-critical process systems to demonstrate compliance to cGMP-, User- and Regulatory requirements. Hands-on activity envisaged in relation to this.
Performs validation of systems in scope for which there is industry precedence but standards require interpretation to the particular case and in accordance with cGMP’s
Ensures that the Validated Status of systems in scope is in compliance with cGMP at all times.
Keeps current on emerging validation regulations and validation testing practices in order to meet or exceed cGMP requirements. Provides technical assistance on current US FDA and EU validation requirements.
Generates validation documentation (protocols/reports) and provides assistance with the execution of protocols for systems in scope.
Responsible for the validation documentation through approval and implementation.
Provides input in review/assessment of changes to as whether they impact the validated status and validation-documentation, as appropriate.

Requirements

Knowledge of CGMP requirements in a regulated environment.
Understanding of relevant quality and compliance regulations.
Capable of troubleshooting validation issues.
Good knowledge of quality management systems
Experience: 2-4 years experience working in a Healthcare manufacturing environment, with experience in qualification of small scale equipment (including the related software).

Terms

Challenging projects based on your interests and skills
Personal follow-up and clear, transparent communication both before and after commencement of employment
Possibility to follow extra training
Inspiring network events and legendary after work drinks
Strong network of industry leading clients
Expertise within IT, Engineering and Life Sciences
A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees

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