Computerized Systems Validation Consultant, Leiden

Computerized Systems Validation Consultant

Adryan Leiden, South Holland, Netherlands Computerized Systems Validation Consultant

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Computerized Systems Validation Consultant Adryan is an internationally operating services group. From our offices in The Netherlands and Switzerland, we offer a full range of services for the (bio) pharmaceutical and high-end food industries. We are specialised in the areas of project management, engineering, CQV and compliance.To strengthen the Adryan team in the Netherlands, we are looking for an

experienced CSV Consultant . You will monitor the quality of processes, systems, equipment and/or software applications, used for research and production of medicines. Key responsibilities:• You develop the validation strategy and carry out validation activities on an R&D site or a production plant (Bio-Tech).• You prepare ‘high level’ documents (Validation master plans, criticality analysis), protocols and scripts, procedures and reports, up to the final delivery. • You may be conducted to supervise a team of validation engineers in the execution of validation activities.• You strictly work according procedures and guidelines. • You report on the progress of these validation activities to the project manager.. Job requirements • You preferably have at least a master or engineer’s degree in a technical or scientific field, linked to life sciences. • Youhave 5 years of experience with computer validation in a GMP environment and you know how to use some of its associated applications (ex.: MES, ERP, LIMS, EBR, QMS/eDMS, etc.).• You have broad/general knowledge on computerized systems and maybe some automation (ex.: data security, data exchange, infrastructure, PLC, SCADA, MES-systems, ERP, etc). • You are familiar with working according GAMP 5, and aware of current insights regarding 21 CFR-part11. • You are ableto work precisely and accurately and in accordance to specific guidelines and rules (ex. GMP, GLP).• You have good communication skills at different (social) levels. • You are self-reliant and organized, with a team spirit. • You have experience with MS Office. • You express yourself fluently in Dutch and English, oral and written. Job offer • A challenging position within a dynamic and rapidly growing organisation.• Inspiring projects within our life sciences network • A good salary, depending on education, knowledge and experience. • An attractive bonus scheme and great benefits, such as a company car, laptop, telephone and a personal training budget. • Being part of our motivated, dedicated and cooperative Adryan team.Do you want to apply as CSV Consultant? Seniority level

Seniority level Associate Employment type

Employment type Full-time Job function

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