PHQ 2463
Switzerland
Client: International Pharmaceutical Company – Headquarter
My client is a Global Pharmaceutical company headquartered in Switzerland. It is currently is seeking a Global eCompliance Manager who will ensure that all aspects of global and local computerized systems are implemented and operated in compliance with GxP regulatory requirements and company’s manuals.
This is an excellent opportunity for individuals to contribute to the continued growth and success that this superb organization is experiencing.
Your responsibilities:
• Contributes to the local and global computerized system validation master plan, global computerized system inventory
• Maintains global CSV standard Operating Procedures and Standards.
• Define, maintain, and continuously improve the CSV standards
• Reviews and/or approves the global and/or local Computerized Systems key validation deliverables and major changes
• Support internal and external audit program in relation with computerized systems
• Supports and/or manages preparations for regulatory inspections and maintains computerized systems validated status.
• Ensure that Computerized Systems related audit follow-up activities are performed in time and within acceptable quality levels according to the global processes
• Identify, report, and successfully resolve potential CSV global or local compliance issues
• Provide or support internal training on Computerized System Validation aspects.
The successful candidate will have:
• University degree in Pharmacy, Chemistry, natural sciences or IT
• Proven experience with IT Quality Management and Computerized Systems Validation aspects of application implementations and operations (e.g. ERP/SAP, DMS, LIMS) in the regulated Pharmaceutical Industry.
• General understanding of GMP
• Sound experience in QA, QA-IT, and IT
• Experience in GxP regulated Pharmaceutical Industry (e.g. in Quality Assurance), IT departments, Quality Management Departments or equivalent Consultant positions with excellent knowledge of the European and US computerized system validation requirements.
• Operational experience (QA, QC) advantageous
SEC PHARMA
Mrs Sarka Cinkova
Tél. : 44-207 255 66 65
Fax : 33-1 70 80 74 89
Sarka.Cinkova@secpharma.com
