(1 year temporary position)
Inside the Quality Assurance team we are looking for someone passionate to support quality and manufacturing organization. Ideal candidate will be in charge of documentation activities, and raw material release. Moreover he/she will be Quality Assurance representative to bring compliance and quality mindset in GMP workshop and research and development area dedicated to the manufacturing of BDS clinical trial products.
From a QA document control perspective
- Perform QA document control activities (issuance of documents, revision, activation, Training system update) in compliance with GMP practice
- manage the flow, approval, issuance and Archiving of GXP related technical documents
- backup as Superuser routine work on eDMS, eQMS, eLMS
From a Manufacturing perspective
- Manage supplier notification for raw materials and assemblies.
- Perform raw material and assemblies release for BDS manufacturing based on Quality agreement, specifications and incoming goods controls.
- Manage deviations for raw materials and supplier complaints as needed
- Review and approval of documents, standard operating procedures, technical documents (URS, drawings, pest control report) related to raw materials and suppliers
- Provide support for inspection by authorities as well as internal and external audits.
- Contribute to the optimization of quality processes based on GMP.
- Perform other relevant duties as required.
EDUCATION AND DESIRED EXPERIENCE:
- BSc, or equivalent biochemical engineering, biochemistry, biology, pharmacy or related discipline
- At least 2 years of experience in an industrial setting under GMP standards or equivalent
- Strong sense of discipline, good organization skills, excellent team orientation and hands-on approach to work
- Autonomous, reactive and flexible to changing priorities
- Fluent English both written and verbal; proficiency in French is highly desirable
You will join us, in a picturesque city of La Chaux-de-Fonds, Neuchâtel, Switzerland.
This is a rare opportunity to join our growing scientific team at the very start of something special. You will become a part of the foundation of a new company imprint…