GMP and Documentation Specialist
4 weken geleden
At Yacht, we are passionate about creating a world without disease. We bring together the best minds and pursue the most promising science to transform lives. Our company is a leader in biomedicines, part of the Johnson & Johnson family of companies. For over 25 years, we have been at the forefront of biotechnology, seeking innovative treatments for cancer, infectious diseases, cardiovascular and metabolic diseases, and immune-mediated inflammatory disorders.
Job Description
We are seeking an enthusiastic and motivated Documentation Specialist to join our 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.
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.
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).
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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