Description
We are looking for a
QA e-Compliance Contractor (m/f)
Reference: -en
Start: asap
Duration: 8 MM
Place: in Basel
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Provide QA eCompliance oversight in order to migrate data and computer systems to other companies that have purchased them along with their associated business processes
- Support QA eCompliance with regard to project deliverables as well as typical day to day operational tasks related to data integrity and the related regulatory requirements
- Provide QA support for GxP impact computer system implementation projects
- Ensure that projects, systems and processes meet the requirements of the client's quality manual
- Provide excellent QA operational support to IT departments, including assistance with GxP decision making, change control review and approval, SOP review and approval as well as review/approval of other GxP-related deliverables as needed
Your qualifications
- B.S. in Computer Science, Engineering, or other similar scientific degree
- Very good knowledge in a GxP environment with a thorough understanding of computer validation
- Knowledge in validation of cloud solutions is beneficial
- Knowledge in 21CFR, Part 11
- Knowledge in EU Annex 11
- Knowledge of typical IT processes
- Knowledge of GAMP5 and its full lifecycle
- Project management skills
- SAP skills
- In-depth working experience in a QA role in a GxP environment
Skills:
- Quality manager
- Compliance manager
Keywords: Qualitätsmanager