Beschreibung
We are looking for a
QA / QC Expert (m/f)
Reference: -en
Start: ASAP
Duration: 6 MM++
Place: in the Canton of Zug
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Responsible for the release of product batches and related packaging materials in close cooperation with the QA GMP and Development Manager as delegated by the Responsible Person
- Conduct vendor assessment and/or qualification visits for locally outsourced GxP activities in close collaboration with QA GMP and Development Manager
- Review documentation of incoming batches of medicinal products, and market actions, Review customer, supplier and product master data, Review records of returned goods
- Review relevant global and local Product Quality Reviews (PQRs)
- Ensure that deviations and issues are properly managed in TrackWise System AQWA, including the respect of the escalation process
- Participate in QA Investigation activities as appropriate
- Support implementation and maintenance the local quality system in the areas of GMP, GDP and GPvP
- Provide support to of the CPO and external service providers during and after HA inspections and internal audits
- Ensure that responses to local health authorities have been submitted, commitments have been met and relevant CAPs have been completed/closed
Your qualifications
- Profound experience in the pharmaceutical industry in a relevant field such as Quality Assurance, Quality Control
- German and English fluent in speaking and writing, knowledge of French desired
- Knowledge of GMP and ICH guidelines
- MS Office skills, experience with SAP and TrackWise
Skills:
- Quality manager