Beschreibung
Quality Assurance Associate IIDuration: 1 year initially, with possible extension
Location: Zug, Switzerland
Description
The person in this function provides support to the management of the local pharmaceutical quality system. He/she also acts as Quality contact for closure of exceptions, CAPAs and change controls related to Quality systems (including IT Quality systems). He/she supports process improvements related to GxP activities, by providing quality oversight. The role may also participate in projects to support enhancements of IT Quality Systems, which may include testing and roll-out of the enhancements to end-users. The role also supports site compliance activities such as advising other departments on GxP compliance aspects, managing preparation for, and follow-up of audits and inspection.
RESPONSIBILITIES
- Support maintenance and improving of the local Pharmaceutical Quality System established to ensure compliance to local regulations and in alignment with the global Corporate Quality System. This includes cross-site alignment for common processes and systems. Follow regulation updates and deploy them when deemed applicable.
- Act as Quality contact for exceptions, CAPAs, and change controls related to Quality Systems (including IT Quality Systems).
- Provide support in the quality oversight for IT Quality systems enhancements and business processes. Support improvements and roll out for those systems to the end users
- Participate as a GEQ Quality Systems representative on cross-functional teams and projects. Give advice on regulatory and compliance question to stakeholders. Address potential gaps for processes or practices within teams and projects to avoid incompliance
- Support general support in Program Management activities, including collection for data for monthly reports, Management Reviews and follow up of action items.
Requirements
- Master Degree / Bachelor Degree in scientific field + 3 years experience in relevant industry or equivalent.
- Quality experience in the pharmaceutical industry
- Knowledge of cGMP requirements, EU/FDA regulations and compliance
- Experience in IT systems qualification & project management
QA, Quality Assurance, Quality Assurance Associate II, Biopharma, Pharmaceuticals, Manufacturing, CAPA, Process, GMP, GxP, Project Management, IT, Systems, Qualification, Switzerland, Zug
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.