Description
We are looking for a
Global QA (eCompliance) Manager (m/f)
Reference: -en
Start: asap
Duration: 3 MM+
Place: in Basel
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Responsibility for providing Quality Assurance support on behalf of the business with regard to computerised systems validation (CSV), operating within the framework of regulations (GxP, 21CFR11, etc.) and requirements defined in global procedures
- Single point of contact for guidance on CSV related topics and related information
- Review and approve relevant system lifecycle documentation relating to validation and validation changes from a content/e-Compliance perspective
- Approve changes and deviations, failure investigation and CAPAs associated with GxP computer systems (operational changes according to change control process)
- Provide guidance on Computerized System Validation (CSV) and Data Integrity
Your qualifications
- Degree in engineering, pharmacy, chemistry, natural sciences, information technology or equivalent experience in the pharmaceutical or a related regulated industry
- Profound experience in CSV and eCompliance-related systems, e.g. SAP in a GxP environment
- Expert knowledge in one of the following: GLP, GCP or GMP compliance in one or more global regulatory requirements (FDA, MHRA, EMA etc.)
- Skilled in risk assessment methodologies and in organising projects
- Fluency in English, German is of advantage
Skills:
- Quality manager