Vacature QA Validation Specialist - QA Validation Specialist

QA Validation specialist

About CHDR

CHDR is an independent institute specializing in innovative, early-stage clinical drug research. CHDR conducts clinical research on new and existing drugs for pharmaceutical companies, but also initiates its own research. By combining cutting edge methods and technologies, state-of-the-art facilities, and talented researchers, we help maximize our clients' success. We are located in Leiden, the Netherlands, and collaborate closely with Leiden University and the clinical departments of the Leiden University Medical Center (LUMC).

CHDR stands for scientific quality, innovation, and collaboration. Employees and test subjects feel at home at CHDR. We deliver top quality in clinical research and are constantly innovating. CHDR employs more than 400 people, conducting more than 60 studies per year on average. By close collaboration with your colleagues, you will complement each other's specialisms such that our customers receive the right service.

QA Validation specialist

CHDR is looking for a validation specialist who will be responsible for setting up and supporting CHDR's validation projects. The validation specialist is part of the QA team, working closely with other departments including IT. The validation specialist reports to the Compliance Director.The work consists of carrying out risk assessments for the existing and new systems, setting up, supporting, and monitoring validation activities and overseeing quality assurance. In addition, an important part of the job includes identifying the needs of the organization in terms of IT quality assurance in relation to laws and regulations.

For this position, we are looking for someone with authority and leadership who can interpret regulations and translate them into practice. You can work both independently and in various team settings. You have affinity with quality and data integrity and can keep these topics high on the agenda within the organization. This position requires knowledge of the services IT provides to the organization, including technical knowledge.

Duties and responsibilities

As a QA Validation specialist you will:

• Develop and maintain quality standards to ensure compliance in the domain of GxP
• Analyze the intended use for both for computer systems including software and laboratory and other measurement systems and set up a validation path, including writing a validation plan, IQ/OQ/PQ protocol and validation report
• Provide support in the execution of the validations.
• Provide support in projects focused on data integrity
• Giving advice and input on IT governance

Job requirements

For this role we are looking for a candidate with the following experiences:

• A completed HBO or master's degree
• Extensive experience in a GxP regulated work field
• QA experience
• Experience with GAMP 5
• Basic IT knowledge
• Very good command of the English language, both oral and written
• Experience with project management is an advantage

Next to that, we are looking for the following core competencies:

• High quality awareness
• Excellent communication skills
• Analytical and problem-solving skills
• Ability to work with details
• Integrity
• Accuracy

Our offer

You will join a dynamic, passionate organization and work within a diverse team in a fast-paced, innovative setting. We offer you a contract for a year (with the prospect of a contract for an indefinite period), 8% holiday allowance and an end-year-bonus in a pleasant hybrid workplace with an open multidisciplinary work environment. Our office is close to Leiden Centraal and we reimburse your costs for public transport for 100%. We facilitate good working from home conditions and organise all kinds of social events.

Application

If you are interested in this position, please send your letter and CV with the green button 'Solliciteren'. For more information about the position, please contact Margreet Rienstra, Compliance Director ). For more information about CHDR visit our website www.chdr.nl.

Functie:	qa validation specialist
Startdatum:	17-02-2024
Ervaring:	Ervaren
Educatielevel:	HBO
Contracttype:	Vast
Salaris:	onbekend – onbekend
Uren per week:	1 – 40

Heb je interesse in deze vacature en wil je graag op deze functie solliciteren? Neem dan contact op met Stichting Centre for Human Drug Research (CHDR) via onbekend of onbekend. Of bezoek hun website onbekend.