Documentalist

ProQR Therapeutics is a clinical-stage biotech company listed on NASDAQ with offices in Leiden, the Netherlands and Cambridge, Massachusetts, ProQR is focused on the development of game changing RNA therapies for severe genetic rare diseases, our mission is to help patients by creating new A team of approximately 100 enthusiastic ProQRians from all walks of life and more than 30 different nationalities is up to this We have the passion and commitment to make a difference in the lives of the patients we

We are currently looking for a Documentalist (Full-time) to join our

The Role:

The documentalist is responsible for the coordination and maintenance of quality documents that are generated within ProQR and externally at our contract This includes documents in the Quality Management System (QMS) such as Policies, SOPs, Records and project-specific GxP data and All the quality documents are controlled in our Document Management System (DMS), which you will become an expert

The role is especially suitable for someone who is interested in starting to gain experience in QA

Key Duties and Responsibilities:

Maintenance of the Quality Management System (QMS):

• Responsible administrator of Rescop (eDMS)
• Ensure the DMS is maintained and remains in a validated state: liaise with the DMS vendor in case of version updates and patches, perform validation testing (PQ) in case of version updates, perform necessary testing in case of patche
• Initiate and manage deviations, changes and CAPAs related to the DMS
• Update procedures related to the DMS and document management
• Provide training to the organization and share best practices with regard to the DMS and document management
• Manage reading tasks and SOP profiles for the organization in eDMS

Documentation Support:

• Upload final documents into the eDMS for approval

• Manage electronic approval of external Quality documents approved outside of the eDMS
• Ensure that paper and electronic documents are appropriately archived, meeting record retention requirements for the document
• Track due dates of Quality Actions ( Audits, Change Controls, Deviations, CAPA, SOP review) and generate metrics
• Support Vendor Management activities, ensuring all required documentation is in place and actions are followed

Metrics:

• Generate metrics on training and quality actions for the management review meeting

Required qualifications:

• HBO or Bachelor level, in the area of life sciences or related
• Preferably 1-3 years of experience in the pharmaceutical industry within GxP environment
• Accurate and a high degree of attention to detail
• Quality mindset
• Responsible with a proactive attitude
• Affinity working with computerized systems
• The ability to work independently
• Proficient in spoken and written English
• Being flexible, analytical, and well-organized
• Hands-on mentality
• A team player and a nice person :)

ProQR as an employer

As an employer, we are a true believer of the value of a workforce in which people from diverse backgrounds are encouraged to develop themselves, personally and We believe that happy and energized people, working well together in an environment in which they thrive, will do phenomenal and awesome

We are committed to ensuring that no employee, candidate or job applicant receives less favorable treatment on the grounds of race, age, disability, pregnancy, religion, gender identity and expression, sexual orientation, marriage or civil partnership stat At ProQR we want to create an inclusive culture where everyone can be valued for who they are and in which individual differences and the contributions in all forms are recognized and

We offer an exciting and innovative working environment in a very committed organization, with the following benefits:

• 8% holiday allowance
• 30 vacation days
• A premium-free pension plan
• A commuting allowance
• A subsidized staff restaurant
• Flexible working arrangements
• Unlimited (un)healthy snacks and drinks
• Employee events (boot camp, chair massage and other social events)

Do you think you can contribute to achieving our mission? If so, we re looking forward to receiving your application by filling out our application

Please apply as soon as possible if you are interested in this

You can contact Silvia Catellani via if you have any

Please note that screening is part of our selection