Beschreibung
QA Manager (m/w/d)Location: Zurich
Duration: 8 months but possibility for extension
Tasks
- Manage interface and interaction with CMO (weekly QA meetings, individual follow up meetings) in regards of batch disposition and investigation progress
- Review batch documentation provided by CMO for completeness, correctness and compliance to Marketing Authorization application.
- Perform internal batch disposition acc. to Companys VBU SOP and acc. to change control status
- Mirror CMO deviations in Companys investigation system, lead investigation with internal and external partners and ensure closure on time
- Weekly status updates to be provided on work package completion
participation in weekly internal QA meeting to update on progress and align on next steps and issue/comment resolution
- Participation in joint CMO QA meeting
Requirements
- Bachelor's Degree or higher in Chemistry, Biology, or Life sciences, or equivalent scientific discipline
- Minimum experience of 6 years in quality or regulatory compliance within the pharmaceuticals, biologics, or other related industries.
- Good Manufacturing Practice quality assurance experience
- Experience with equipment, instrument, analytical method and process validation is an asset
- Excellent communication skills both oral and written.
- Effectively represent Quality Assurance, both internally and externally
- Experience in routine office software packages and specialized software applications as appropriate.
- Exhibit and promote Companys Core Competencies.
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.