Yacht Life Sciences has a vacancy for a GMP and Documentation Specialist at Janssen Vaccines & Prevention in Leiden.
The GMP and Documentation specialist within the Janssen Pilot Facility is the first point of contact within the production teams for questions related to cGMP (training, inspections, audits and documentation). In different team settings, you will work on the maintenance and improvement of the available cGMP systems.
The GMP and Documentation specialist has a detailed understanding of cGMP and GMP documentation systems, such as Veeva truVault. You are an expert in handling non-conformances and follow-up. With process excellence/lean experience, you are able to identify and lead compliance improvement projects.
As GMP and Documentation specialist, you will be responsible for:
- First departmental contact for questions about cGMP systems
- Initiating and handling of compliance records (Change Control, non-conformances and CAPA records) including root cause analysis
- Supporting/leading in keeping process documentation up-to-date
- Coordinating training system within the department
- System ownership of general production processes like gowning, routing and flow, segregation
- Leading role in the inspection readiness of the department, execution of inspections and follow up
- Working accurately and detecting opportunities for improvement with proper follow up, both on compliance work processes as well as personal development
- Bachelor or Master degree with 3 years of proven experience in pharmaceutical/biotechnology
- Experience with change controls, non-conformances, CAPA records, other quality controlled documentation is a must
- Experience working under GMP conditions is a must
- Lean green belt certification is preferred
- has a high degree of accuracy, initiative, and independence
- is flexible and stress-resistant and remains positive when priorities change
- helps team members by giving advice and sharing feedback
- communicates clearly in English, both verbally and in writing.
Terms of employment:
We offer a challenging secondment position for 1 year, which allows you to work in a dynamic and international environment, ensuring diversity in your work and creating plenty of opportunities for personal development.
We will offer a competitive benefit package in line with the seniority of the position (salary between 3200 and 4200 euro gross per 4 week period).
You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and to become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers, you will be able to follow courses and training via our Yacht Academy in order to keep your knowledge and skills up-to-date, i.e. boosting your career through personal and scientific growth.
About the Company:
Janssen Vaccines & Prevention B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson and is passionate about the development, production and marketing of vaccines to prevent and combat infectious diseases. The Drug Substance Operations (DSO) department has a GMP manufacturing facility at the Bioscience Park in Leiden where they proudly produce groundbreaking medicines against diseases that have a global impact, such as vaccines against HIV, RSV and Ebola. This is also the place where they are producing the COVID-19 vaccine material.
The department DSO is an international team of about 50 people working on the manufacturing of cell banks, virus seeds and clinical batches (phase I to III) to support the development of new vaccine candidates. Manufacturing activities are performed under strict cGMP regulations and the process is established together with development departments, engineering & maintenance, QC, QA and warehouse. Their passion is to deliver high-quality results to our customers and to seek for opportunities for improvement: never a dull moment!
Within the department four teams operate, each with specific responsibilities: Preparations, Cell culture, Downstream processing and the Operations Support Team. The teams are responsible for their cGMP status by maintaining the documentation system, reporting quality issues and performing the resulting corrective actions, master batch documentation, training and inspection readiness.
Inclusiviteit en diversiteit
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag.