Documentation Specialist

  • Leiden, Netherlands
  • Full-time

Company Description

Eurofins Scientific is an international life sciences company, which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the leading global emerging players in specialty clinical diagnostic testing.

In 2018, Eurofins generated 4.2 billion Euro proforma turnover in 800 laboratories across 47 countries, employing about 45.000 staff.

PSS Insourcing Solutions (PSS) is an award-winning solution for pharmaceutical companies. At the request of pharmaceutical customers, PSS provides dedicated, qualified and trained Eurofins personnel who work at a customer’s location using customer facilities, equipment, computer systems, SOPs and methods. Our employees work on a predefined project or activities at the customer’s location. PSS employs around 1.700 employees worldwide. In the Netherlands you get about 100 enthusiastic colleagues, spread over five customer locations.

We offer you a career with a world leader in the field op lab expertise. At PSS, collegiality, collaboration, customer focus and delivering high-quality work are paramount.

Job Description

For our location in the Leiden we are looking for an enthusiastic Documentation Specialist to join the team. The department focusses on manufacturing support and innovation studies as well as production of products for clinical studies also known as NPI projects. This Specialist will support preparation and updates of GMP documentation. Primarily, this role will focus on creation and controlling the status of document routing, and guiding related change controls through the relevant systems.

-          Contribute to the development, standardization and introduction of new products (NPI’s). This requires a good understanding of the organizational structure. This task entails highly complex structures with different stakeholders;

-          Contribute to project planning through maintaining the scheduling map and distributing meeting invitations, as well as supporting the documentation of the project;

-          The documentation support also includes ensuring a timely availability, controlling the status of document routing, and helping to identify bottlenecks and risks in the documentation process;

-          Being initiator and owner of project related change controls. This includes planning and organizing work-cell meetings, and guiding the change controls through the relevant systems. This guidance also means protecting deadlines, collection and combining of input and coordinating feedback and approval cycles.

Qualifications

  • Bachelor's degree with 2 years of relevant experience in pharmaceutical industry;
  • Knowledge of GMP regulation;
  • Extended experience with Microsoft Word and Excel spreadsheet creation/management;
  • Ability to manage competing priorities and timelines in a fast-paced, dynamic environment, and stress-resistant;
  • Ability to work collaboratively with cross-functional teams;
  • Good communication in Dutch and English, both verbally and in writing.

Additional Information

Working at PSS means working with highly motivated people with a can-do mentality. Our people work in an international environment, within an enthusiastic team and for an organization where there is sufficient room to develop further. Working together is extremely important to us and having fun in what you do is part of that! Our monthly team lunches, team activities and the hand out of awards to our colleagues are an example of this. We also offer:

A responsible and challenging position within the team;

Plenty of room for your own ideas and input;

Specialist training and a range of opportunities for personal and professional development;

Flexible working hours;

Good salary and benefits.

Working at PSS offers you the flexibility and personal touch of working in a medium sized and dynamic company, whilst also allowing you to benefit from having Eurofins as a parent company. Our ambitious growth plans provide ample opportunities for the motivated employees:

Plenty of opportunities for growth;

Varied work where you are in regular contact with other companies and scientists within the Eurofins group;

A broad customer portfolio ensuring a lot of diversity in your work.

Would you like to know more?

For questions regarding the position, please contact our Human Resources Department at 071 524 40 80 or responsible manager at +31 6 15292701

Acquisition for this vacancy is not appreciated.

 

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