Validation Officer / Biotech / Temporary* / The Netherlands / GMP, GLP + GxP

Location: Netherlands

SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical and Biotechnology organisation, based in Netherlands.

The Company

Our client is a leader in the strongly growing and very dynamic market of diagnostic services companies. They offer serological, virus-based and molecular analyses of any type of sample and combine this with a global logistics service network. Their analyses encompass many types of viruses.

Role Description

You will work in the region of South-Holland, where our client is located. You will strengthen the Validation team to ensure the validation of all computerized systems within the company of our client. How? By documenting that the systems do what they are supposed to do.

Responsibilities

Your responsibilities as an Validation Officer are planning and executing validation activities and the creation of validation documentation; preparing CSV documentation, Plans, Protocols and Reports and creating procedures with respect to the validation activities;

Also executing and reporting validation protocols in accordance with the appropriate regulations for quality, health and safety; ensuring site activities associated with validation are in compliance with our quality management system requirements (including GMP requirements); ensuring routine validation challenges are resolved in a compliant, effective and timely manner; archiving site validation documentation and completion of validation risk assessments; scheduling and coordinating review of equipment validation and re-validation and occasionally participate in audits and perform risk assessments are important responsibilities of an Validation Officer.

Requirements

Our client is looking for a colleague who has a quality driven mindset and who is able to prioritize. Good communication skills is very important. It means that it is a must to have excellent English language skill, verbally and written, as you will work together with several other departments. Other requirements are:

Preferred: Work experience in a pharmaceutical environment;
Completed education at MBO/HBO level in a Biological, Engineering or IT discipline;
Preferred: Understanding of/experience with GxP procedures;
Knowledge and/or affinity with ICT and computerized systems;
Preferred: knowledge of GAMP5, 21 CFR part 11 and/or EU Annex 11, OECD series on principles of GLP and compliance monitoring No.17 – Computerized systems.

Other information

Good to know: The open position is an parttime (32 hours) or fulltime (40 hours) position. The position is *temporary for a period between 12 - 18 months. Furthermore, you will receive 8% holiday allowance and travel allowance.