For our client, an international biopharmaceutical company, active in the fields of reproductive health, urology, gastroenterology, endocrinology and orthopedics, we are looking for a:
QA Pilot Plant
In your role as QA, you will be working at the Pilot Plan within the innovation center, a global department, which will require cross-functional interaction and presentations.
As part of the innovation center and in the scope of the creation of a new entity for the development of a new sterile micro-particle manufacturing of clinical batches, this role is key to ensure project and process compliance with GMP.
Acting as a support to the Pilot Plant QP and project team, you will be performing a variety of tasks:
1. QA Project:
- CoC definition
- Batch record review
- Equipment qualification (Support and author of IOQs?)
- Sterility and cleaning validation support
- Environmental control and microbial release strategy support
- Release strategy definition
- Contamination control strategy major support
2. QMS implementation support:
- Quality system SOPs creation
- Technical agreement definitions
- Quality system implementation support
- SwissMedic PAI preparation support
3. Manufacturing support:
- Quality on the floor for GMP compliance manufacturing
- Internal audit conduction for PAI preparation
* University degree in Pharmacy, Chemistry or alternative technical/science university degree: master level minimum, PhD or PharmD preferred
* Minimum of 5 years' experience in Quality Assurance in pharmaceutical industry
* Excellent knowledge of relevant GMP and international quality regulations
* Knowledge in sterile manufacturing environment
* Sound knowledge of written and spoken French and English is required
* Strong and effective verbal and written communication skills
* High level of autonomy and energy
Does this role interest you?
Do not hesitate to apply directly online!
We look forward to receiving your application and please note we will get in contact only with the selected candidates.