Consultant in Computer Validation

Trevalco BV; Aartselaar; Sur place; EUR 45 000 - 65 000; Plein temps

Avantages offerts par ce poste

CAO90 bonus

Hospitalisation insurance

Dental care insurance

Meal vouchers

Company car or mobility budget

Training (coaching, classroom or e‑ded

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Fluent in English

Fluent in Dutch

Analytical skills

Documentation management

Commercial communication

Affinity with ICT

Formation

Master degree in science or engineering

Description du poste

A job in computer validationrequires technical analysis, document writing, execution of tests onsoftware or automated systems, as well as a lot of interaction withdifferent departments in the company where you work.

As CSV consultantyou execute computer validation projects on location at apharmaceutical company or from our offices. You are involved with theanalysis of user requirements, testing and implementation of newsoftware solutions.

For this position we are looking at all levels of experience, from starter to senior level.

Your responsibilities as CSV consultant include:

• develop a validation strategy which is realistic andmeets current regulatory and client expectations, write validation planand report
• writeURS
• 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 as21CFR Part 11 or Eudralex annex 11, taking into account current trendsand vision of the client
• take decisions which properly balance out quality / budget / planningand help project stakeholders to reach a compromise on critical qualitydecisions

Must have

• 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.
• AffinitywithICT.
• Master degree in science or engineering, or equivalent through experience.
  

Nice to have

• Experience working in a GxP environment.
  
• Experience in computer validation related roles such as tester or technical writer.
  

What is great about this job?

• As a consultant, you will find yourself working with exciting companies in the Life Sciences sector.
• You will use your knowledge and skills to tackle challenges faced by our clients.
• A consultancy job can be a calling, or a springboard to the start of a career as a technical expert, people manager, or multipotential.
• Trevalco is not a multinational with thousands of employees, but a Belgian SME, so you are not just a number with us.

As an employer, we contribute to the success of your career. Proper guidance and training are very important to us. Naturally, we also ensure that you feel good in your job through a healthy work/life balance, a market-competitive salary, and tailored solutions for aspects such as mobility.

CAO90 bonus, hospitalisation and dental care insurance, meal vouchers and more

Mobility

you choose what works best: company car or mobility budget

Training

coaching, classroom or digital online training, what works for you

Work / life

because we have families, friends and hobbies