Description
We are looking for a
Global QA (e-Compliance) Manager (m/f)
Reference: -en
Start: asap
Duration: 8 MM+
Place: in Basel
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Responsible for providing Quality Assurance support on behalf of the business with regard to computerized systems validation (CSV), operating within a framework of regulations (GxP, 21CFR11 etc.) and requirements defined in global procedures
- Act as the single point of contact for guidance on CSV-related topics and related information
- Review and approve relevant system lifecycle documentation related 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
- Act as the interface between the business, the IT and the QA organizations for CSV-related topics
- Report performance metrics and project status updates where relevant to Global QA (e-Compliance) Manager (Pharma QSS)
- Report potential CSV global compliance issues
- Contributes to managing, assessing and resolving GxP-critical deviations from an e-Compliance perspective
Your qualifications
- Graduate in Engineering, Pharmacy, Chemistry, Natural Sciences, Information Technology or profound equivalent experience in the pharmaceutical or a related regulated industry
- Combined in-depth experience in the fileds of risk management, Quality Assurance, information security, compliance and IT
- Strong working knowledge of CSV- and e-Compliance-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 environments (FDA, MHRA, EMA etc.)
- Working knowledge in all areas of compliance in one or more global regulatory requirements
- Ability to negotiate favorable outcomes while maintaining positive working relationship
- Skilled in risk assessment methodologies and project organization
- Fluency in English, German is of advantage
- Ability to communicate quality-, compliance-, security- and risk-related concepts to technical and non-technical audiences
- Strong organizational and IT project management skills, scheduling and resource management skills
- Familiarity with compliance requirements (e.g. FDA, EMA GMP, GLP, GCP, records management, BC/Disaster Recovery)
Skills:
- Quality assurance professional
Keywords: Qualitätssicherer QS QA Quality FDM EMA GLP GxP GMP CSV compliance