CSV Consultant – Computer Validation for Life Sciences

Trevalco BV; Aartselaar; On-site; EUR 45,000 - 65,000; Full time

Benefits offered by this job

CAO90 bonus

Hospitalisation insurance

Dental care insurance

Meal vouchers

Company car or mobility budget

Training (coaching, classroom or e‑ded

Job summary

Trevalco BV is seeking a CSV consultant to lead computer validation efforts for life sciences clients, either on-site at a pharma company or from our offices in Belgium.

You will analyze user requirements, design validation strategies, write URS and IQ/OQ/PQ documents, and plan and execute tests. You will also manage deviations, CAPAs and change controls while ensuring regulatory alignment with 21 CFR Part 11 / Eudralex annex 11.

Qualifications

• Fluent in English and Dutch.
• Strong analytical skills, well organized, studious and precise.
• You enjoy managing documentation: creating documents, reviewing and updating, getting approval on documents.
• Commercial, able to convince clients by communicating in a clear, enthusiastic way.
• Affinity with ICT.
• Master degree in science or engineering, or equivalent through experience.

Responsibilities

• Develop a validation strategy which is realistic and meets current regulatory and client expectations, write validation plan and report.
• Write URS.
• Write IQ, OQ and PQ protocol (or other relevant test documents).
• Plan and execute or oversee execution of computer validation tests.
• Manage quality records such as deviations, CAPA's and change controls.
• Participate to risk assessments and quality investigations.
• Ensure compliance to regulatory requirements such as 21CFR Part 11 or Eudralex annex 11, taking into account current trends and vision of the client.
• Take decisions which properly balance out quality / budget / planning and help project stakeholders to reach a compromise on critical quality decisions.

Skills

Fluent in English

Fluent in Dutch

Analytical skills

Documentation management

Commercial communication

Affinity with ICT

Education

Master degree in science or engineering

Job description

Trevalco BV is seeking a CSV consultant to lead computer validation efforts for life sciences clients, either on-site at a pharma company or from our offices in Belgium.

You will analyze user requirements, design validation strategies, write URS and IQ/OQ/PQ documents, and plan and execute tests. You will also manage deviations, CAPAs and change controls while ensuring regulatory alignment with 21 CFR Part 11 / Eudralex annex 11.