In this position you will be acting as a quality expert and consult your internal colleagues and external partners on all matters of quality. As such you interact with a varity of contract testing and manufacturing partners and help to ensure the quality requirements in challenging development projects of biosimilars.
- QM representative for assigned biosimilar projects from early development till pre-commercialization
- Be a member of the project team and enforce compliance with internal and cGxP requirements at each single project step
- Review of external quality relevant documentation, e.g., validation, batch records, analytical methods
- Provide quality input and organize review and approval of project related changes, deviations, OOx and investigations
- Prepare briefings and data summaries e.g. product specification files
- Assure qualification of all suppliers among the projects
- Responsible for drafting, and concluding of Quality Agreements with third parties
- In perspective release of IMP batches for clinical supply
- Support continuous improvement of Formycon’s QMS
Bring us your skills and energy, and shape your own career in a stimulating and open work environment. We are looking for highly motivated individuals who are ready to take on new challenges with enthusiasm and personal commitment. Working at Formycon means being part of a smart, innovative team with minimal hierarchy and opportunity to share your own ideas.
Have we sparked your interest? Then we look forward to receiving your application for employment through our online application portal. Please be sure to include all supporting documents, along with your earliest possible starting date and your salary expectations. We look forward to learning about you and the qualifications which you would bring to this position.