GMP and Documentation specialist (Yacht Life Sciences)
| Branche | Zie onder |
| Dienstverband | Zie onder |
| Uren | Zie onder |
| Locatie | Leiden |
| Opleidingsniveau | Zie onder |
| Organisatie | Yacht |
| Contactpersoon | Zie onder |
Informatie
About the Company
At Johnson & Johnson Innovative Medicine, they are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure diseases inspires us. They bring together the best minds and pursue the most promising science.
Johnson & Johnson Innovative Medicine is a leader in biomedicines, part of the Johnson & Johnson family of companies. For over 25 years, they have been at the forefront of biotechnology, seeking innovative treatments for cancer, infectious diseases, cardiovascular and metabolic diseases, and immune-mediated inflammatory disorders. Their Quality Assurance department ensures GMP standards are applied and provides critical advice on quality topics across the supply chain.
Why YACHT?
Because of challenging positions at leading (biotech) companies, a network and development opportunities! These are the advantages of working via YACHT. With us, you will get all the space to grow further. Together we will look for assignments that suit your ambitions and help you to realize your goals. Through coaching, for example, but also by inviting you to interesting courses, knowledge sessions and inspiring meetings.
Through us, you will get access to a network of professionals and companies that are happy to share their knowledge and opportunities with you.
Functieomschrijving
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).
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.
Omschrijving
About the Company
At Johnson & Johnson Innovative Medicine, they are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure diseases inspires us. They bring together the best minds and pursue the most promising science.
Johnson & Johnson Innovative Medicine is a leader in biomedicines, part of the Johnson & Johnson family of companies. For over 25 years, they have been at the forefront of biotechnology, seeking innovative treatments for cancer, infectious diseases, cardiovascular and metabolic diseases, and immune-mediated inflammatory disorders. Their Quality Assurance department ensures GMP standards are applied and provides critical advice on quality topics across the supply chain.
Why YACHT?
Because of challenging positions at leading (biotech) companies, a network and development opportunities! These are the advantages of working via YACHT. With us, you will get all the space to grow further. Together we will look for assignments that suit your ambitions and help you to realize your goals. Through coaching, for example, but also by inviting you to interesting courses, knowledge sessions and inspiring meetings.
Through us, you will get access to a network of professionals and companies that are happy to share their knowledge and opportunities with you.
Functieomschrijving
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).
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.
