GMP and Documentation Specialist

PUB275523

About this job

  • Branche: Pharmaceutical
  • Area of expertise: Medical
  • Location: Leiden

What is required?

  • Hours per week: 40
  • Education level: Academic Bachelor
  • Closing date: Sunday, August 1, 2021

About this role

The GMP and Documentation specialist is the first point of contact within the production teams for questions related to cGMP (training, inspections, audits and documentation). In different team settings, you will work on the maintenance and improvement of the available cGMP systems.

The candidate has a detailed understanding of cGMP and GMP documentation systems, such as Veeva truVault. She/he is an expert in handling non-conformances and follow- up. With process excellence/lean experience you are able to identify and lead compliance improvement projects.

As GMP and Documentation specialist, you will be responsible for:

  • First departmental contact for questions about cGMP systems
  • Initiating and handling of compliance records (Change Control, nonconformances and CAPA records) including root cause analysis
  • Supporting/leading in keeping process documentation up-to-date
  • Coordinating training system within the department
  • System ownership of general production processes like gowning, routing and flow, segregation
  • Leading role in the inspection readiness of the department, execution of inspections and follow up
  • Working accurately and detecting opportunities for improvement with proper follow up, both on compliance work processes as well as personal development

Requirements

  • HBO/BSc with 3 years of proven experience in pharmaceutical/biotechnology
  • Experience with change controls, non-conformances and CAPA records
  • Experience with cGMP and EHSS standards is required
  • Lean green belt certification
  • High degree of accuracy, initiative, and independence
  • Flexible and stress-resistant and remains positive when priorities change
  • Helps team members by giving advice and sharing feedback
  • Communicates clearly in English, both verbally and in writing.

Benefits

Being intermediated by Brunel means that you are contracted by Brunel. Not only you will have a contract, you will as well be assured of a great career.

Our primary and secondary terms of work are excellent. A few examples are price reductions at CZ Health Insurance, bonus opportunities and standard 26 days off. Brunel Engineering intermediates both Junior and Senior Engineers within the industry for over 30 years now. Our clients vary from multinationals to local companies.

Together we will find the job which meets your wishes. Since you are living in another country and probably don't immediately know how to find your way in the Netherlands, Brunel can help you with this. As an international company, we know better than anyone what it is like to move to a foreign country to work. This is why we can arrange the most important things - including those that don't involve your job - for you and your partner so that you can fully focus on your career in the Netherlands.

Join the Brunel Community

Brunel has a large network of high tech organizations. Depending on your own ambitions and preferences we'll always be able to find the right project for you. One of our focus clients, for example, is a leading and international organization in the development, production and sales of high end lithography systems for the semiconductor industry. Worldwide they have over 12.000 employees who all share the same passion for technology with a customer focus. Interested in joining our network? Apply now.

Start applying immediately

Sending an application is quick and easy. Just make sure you have the required documents ready to go.

  • Recent cv
  • Diploma's/certificaten (optioneel)
  • Referenties (optioneel)
  • Motivatiebrief (optioneel)
Apply now

Any questions remaining?

Your consultant, Oksana Gnatiuk is happy to clarify anything about this vacancy. When reaching out, use the pub number:
PUB275523

Account manager

Oksana Gnatiuk
Brunel Netherlands Eindhoven
o.gnatiuk@brunel.net

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