Qiality Assurance Specialist (Yacht Life Sciences)
FlexSpot®Job Description
Yacht Life Sciences has a vacancy for a Quality Assurance Specialist to work at Johnson & Johnson Innovative Medicine in Leiden.
Your main tasks as a QA Specialist:
The QA Specialist acts as a quality expert and applies our Quality Systems to create, review and approve GMP documentation. The contractor works in close collaboration with other departments (Operations, QC, Planning, R&D etc.)
The activities include, but are not limited to:
- Paper and electronic batch record review
- Raw material release
- Document revisions review and approval
- Review and approve analytical method transfer protocols and reports
- Review and approve change controls, validation protocols and reports, validation assessments, and applicable lifecycle documentation depending on experience.
- Track and monitor progress of changes to anticipate, flag and prevent any delays in change implementation.
- Depending on experience supporting master material changes
Functie-eisen
Job requirements
- BSc/HBO (or equivalent) or master’s degree in bioscience, biotechnology, biochemistry, pharmacy biomedicine, process technology
- >4 years of QA experience in pharmaceutical or related industry;
- Up-to-date knowledge of current GMP regulations;
- Experience in Change control and all documenting related activities;
- Experience with documentation systems like Trackwise, True Vault is preferable;
Competenties
Competencies
- Good communicative and advisory skills in English, both (verbal and written), good understanding of Dutch;
- Able to work independently as well as in a team
- Analytical ability, capability to take care of complex issues.
- Flexible, can deal with changing priorities.
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 1 year via Yacht. Full-time (40h) is strongly preferred, working 32 or 36 hours per week can be discussed.
We will offer a competitive benefit package in line with your seniority and the seniority of the position. Salary between 3900 and 4900 gross per 4 weeks period.
Bedrijfsinformatie
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 is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Why YACHT?
Because of challenging positions at leading (biotech) companies, a large 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.
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.