Description
We are looking for a
QC Specialist Primary Container Systems (m/f)
Reference: -en
Start: asap
Duration: 12 MM++
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Writing of internal release specifications, derived from existing supply specifications and essential requirements for primary container closure systems, all under the consideration of cGMP requirements
- Responsibility for the adequacy and Good Document Practice of all technical documentation
- Coordinate documents on the basis of existing documentation management systems
- Support the working group by facilitating TCs and workshops and participate actively
- Maintenance of documentation in established systems (e.g. share drive, touch point)
- Support the leader of the working group in administrative activities
- Close cooperation with Direct Material Specification Lifecycle Team
Your qualifications
- University level education, preferably with an engineering degree
- First experience in pharmaceutic excipients, primary packaging and/or the medical device industry
- Experience of working in pharmaceuticals or other closely-regulated environments under cGxP, QSR or similar working practices
- Sound knowledge of legislation, regulation, industry standards and guidance around the area of primary container closure systems, combination products and medical devices
- Demonstrable knowledge of primary container closure materials (e.g. glass and elastomers) and Container closure integrity
Skills:
- Quality manager
Keywords: Qualitätsmanager