An exciting opportunity has arisen for an experienced Quality Specialist to join an Icelandic company. This company has established itself as a fully integrated biopharmaceutical company, ranging from cell line development of biosimilars to manufacturing, clinical development and registrations. Their manufacturing process is based on 1,000L and 2,000L single use bioreactor fermentation design and has a total capacity of 16,000L and is run almost totally on renewable energy. Their assets include six biosimilar monoclonal antibodies (mAbs).
Suitable candidates will need to possess skills/experience in the following areas: -
- Working as a QA contact person with API as an area of responsibility.
- Provide general QA expertise and support for API
- Provide QA expertise during the investigations of Deviations or OOS; and QA approve these and their related CAPAs.
- Support and approve Change Control records
- Participate in CAPAs resolution of inspection findings.
- QA review and approval of product specifications, master batch records and other quality records related to the API process.
- Review of batch records and associated documents from API before a formal release to the next manufacturing step
- Draft, review and approval of Quality Operations SOPs and of documents from areas of responsibility
- QA review and release of Cell Banks