GMP and Documentation specialist – Johnson & Johnson Innovative Medicine – Leiden

Job Description

Yacht Life Sciences has a vacancy for a Documentation Specialist to work at Johnson & Johnson Innovative Medicine in Leiden at the Operations team.

We are seeking an enthusiastic and motivated Documentation Specialist to join their Operations team. Your primary responsibility will be to check translated work instructions using a translation application and ensure these documents are routed through our documentation process with the correct GMP status. You will collaborate with specialists to discuss the translations and ensure the essence is captured in the wording.

Your responsibilities:

Verify translated work instructions for accuracy and compliance with GMP standards.

Route documents through the documentation process, ensuring correct GMP status.

Collaborate closely with Operations departments and specialists to discuss translations.

Review and approve routine GMP documentation for all components of the Quality system.

Participate in inter-departmental improvement initiatives using the A3 process.

Provide site support for local projects involving the Quality system.

Act as a quality representative at routine site meetings and Quality on the floor activities.

Functie-eisen

Job requirements

BSc in a science-related subject and/or business-related area with 2 years of experience, in Life Sciences, Biotechnology or similar; or MSc in a science-related subject and/or business-related area with no experience.

Affinity and/or experience with GMP regulation

Excellent communication in both, English and Dutch (written and verbally).

Competenties

Competencies

Ability to manage diversity and conflicting viewpoints within production teams.

Strong collaboration skills in a fast-paced environment.

Excellent communication skills to understand and meet customer needs.

Accurate

Arbeidsvoorwaarden

Terms of employment
We offer a challenging position which allows you to work in a dynamic and international environment, ensuring diversity in your work and creating plenty of opportunities for personal development. 
This concerns a secondment contract for one year via Yacht with an initial assignment for 12 months at Johnson & Johnson.
We will offer a competitive benefit package in line with the seniority of the position. Salary between 2500 and 3750 euro gross (per 4-week period).
Working full-time, 40 hours per week is preferred (36 hours can be discussed), on location, but it is also possible to work remote 2 days in the week.

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