- Support GMP documentation, USP/DSP perspective
- Team is support for manufacturing batches on the floor and preparation training operators before the new process is performed
- Rootcause, CAPA and problem impact analyses
- Not handling the process ourselves but the following - Training, Docs, Planning new activities, implementing new equipment, coordination with Operators.
- 12 week tech transfer projects, late phase clinical products, new products;
- Role is a day shift; Mon- Fri
- Bridge between project and operations teams
- Daily teams (NPI) improvements of commercial products (10-20 years improvements, new process).
Skills & Experience:
- Candidate need to have experience in tech transfer projects, Upstream or downstream
- Pharma is preferred, food is a possibility but GMP doc. and tech transfer exp. is very important
- Need to know about Biologics processes, GMP, cell culture experience
- Best case someone with HBO and 4-6 years work experience, Master student with 1,5 years very relevant experience also okay given personal skills match (experienced person from shop floor).
Ownership, independent, easily stand for a group and train, need to connect (relationship/communication)
- Dare to escalate (different persons, spider in the web)
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!
This pharmaceutical division is committed to introducing, manufacturing and finalizing new clinical research products to solve today's key medical needs in oncology, immunology, dermatology and many other fields. We bring innovative products, services and solutions to people around the world and strive to empower them through awareness raising and access to quality care. We are a “bridge” between the operation and the project team in order to implement practical solutions, which you contribute to in this role as New Product Introduction Process Specialist.
Yacht is a contractor for highly educated professionals (BSc, MSc, or PhD) who’ll work on-site and innovate together with our customers to find smart solutions. Being part of the worldwide Randstad Group we have an extensive network of clients and professionals.
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.