Ardena is a leading contract development organization for the pharmaceutical industry. We assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. We provide a comprehensive and integrated portfolio of drug substance and drug product development services. We strongly believe that our multidisciplinary approach can accelerate the drug development and approval process. By seamlessly integrating our services, we’re able to better mitigate development risks and ultimately reduce time-to clinic.
Ardena is a rapidly growing international orientated organization in the industry, with 7 company sites in 5 countries. (Belgium, the Netherlands, Spain, Latvia and Sweden). Each Business Unit has its specialization. The organizations specialties are complementary to each other and created One Ardena Group. We currently have over 400 people working for us and have realized an average growth of 15% on annual basis over the past 3 years. We are ambitious! For you the possibility to expand and transfer your knowledge, grow and develop with us.
For the Ardena Business Unit based in Assen The Netherlands, we are looking for a
(Junior) Validation Officer
WHAT WILL YOU WORK ON
Ardena Bioanalysis (Assen, the Netherlands) is a highly specialized and innovative organization that offers a full range of bioanalytical services from drug discovery research up to phase IV clinical studies. In our recently expanded and renovated GLP compliant laboratory our mission is state-of-the-art quantitative analysis of all types of drug compounds, their metabolites, as well as biomarkers in biological matrices using LC-MS/MS, ligand binding assays and flow cytometry.
The expertise of our enthusiastic team of over 90 highly educated bioanalytical scientists varies from small molecules to proteins including antibodies, antibody drug conjugates, oligonucleotides, and vaccines.
Ardena is a knowledge driven organization. An enthusiastic highly qualified team collaborates in a professional and informal atmosphere.
YOUR KEY RESPONSIBILITIES
As a (junior) validation officer you will be mainly involved in the creation and review of all necessary documentation and procedures during the lifecycle of computerized systems and equipment in the laboratory, from the installation to retirement. Amongst others, you will be responsible for the following activities:
- Creation of user requirements specifications together with key users
- Performing risk assessments for using equipment and software
- Creation of test scripts for validation of equipment and software
- Execution of test scripts and documentation of test results
- Writing validation reports
- Review of validation dossiers and equipment files.
- Performing change control procedures (change requests, close outs, retirements, …)
- Periodic review, audit trail review and user review of computerized systems
- Review/improvement of procedures
YOUR PROFILE LOOKS LIKE/ RESEMBLES
- You have experience with GxP
- You have experience with computerized system validation
- You have medium or higher professional level of education (MBO, HBO)
- You have strong communication skills and are able to listen in order to analyze requirements and risks.
- You are proactive
- You are quality minded and pay attention to detail.
WHAT WE OFFER
- A true learning environment where you will have the ability to grow your skills
- A rapidly International developing and growing company with an interesting services, product and customer portfolio
- A dynamic working environment with nice colleagues
- Open straightforward but also caring culture
- We are true to our values
- An attractive remuneration package
- Flexible working hours
- 28 days holiday a year
If you like to have more information about the role, please do not hesitate to contact Karel de Jonge (firstname.lastname@example.org), Tel: +31 592 344211.
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Only candidates eligible to work in the EU will be considered for the position. Unfortunately, given the high volume of applications we receive for our vacancies, these professionals (not entitled to work in the European Union) will not be given a status update. Agency calls will not be appreciated.