The pressure on vaccinations is growing enormously. More and more companies are involved in the production, packaging or shipping of vaccine products. Quality assurance professionals have never been more important. In addition to the QA on life science, there are also many products / medical devices where specialists are needed. Do you want to contribute to something good? Then we are looking for you!
The department ''QA Operations Commercial Products'' at Johnson & Johnson in Leiden generates and manages several quality systems and is responsible for the release of products. In addition to the team, they are looking for a Quality Assurance Officer.
Main focus areas involve batch documentation review, approve incoming raw material requests and subsequent release. Other reviews and assessments are performed for but not limited to document changes, change control, and validation-related documents. The division also provides advice on quality-related issues to the various products and production supporting departments and plays an active role in several projects, such as the Manufacturing Execution Systems (MES) project.
- BSc/MSc in bioscience or pharmacy or equivalent;
- Up to date knowledge of current GMP regulations;
- Good communicative and advisory skills in both Dutch and English (verbal and written); •
- Good investigative abilities, critical and highly accurate;
- Able to work independently as well as working well within a team;
- Preferably some years of work experience in pharmaceutical or related industry (QA, QC, Production Operations or supporting functions);
- Able to work with and preferably have knowledge of automated systems.
- Judgement of quality and documentation;
- Pharma/medical devices background;
- Job mainly onsite in Leiden: 3 days onsite in Leiden, 2 days remote possible;
- English a must-have - Basic NL skills desirable (Documentation is in both NL + EN);
- Min. 3 years of work experience;
- Happy to work within the area of batch work and review (Documentation Specialist);
- Experience in change control would be a plus;
- Nice to have: CI mindset, Lean thinking.
First a temporary contract. Salary based on experience, 25 holidays + 11, min. 32 hours per week, 40 hours preferred. Job is onsite in Leiden, but remote work can be aligned from time to time.
We will boost your career through personal and technical growth. We’ll support you by offering a personal coach and the possibility to follow courses and training via our highly recommended Yacht Academy. We’ll offer interesting benefits and a market conform salary. You’ll become member of the team of professionals who share your education, ambitions and your competencies.
This will enable you to interact with your colleagues from Yacht in your own technology language! You’ll become a member of the yacht network, which stretches the high tech industry. You will be challenged by your peers. As a result you’ll be able to keep your knowledge and skills up-to-date!
The department ''QA Operations Commercial Products'' at J&J generates and manages several quality systems and is responsible for the release of products. The division also provides advice on quality-related issues to the various products and production supporting departments and plays an active role in several projects, such as the Manufacturing Execution Systems (MES) project.
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.