Description
A global pharmaceutical organisation is looking for a global eCompliance Manager for a 6 month contract role based in Holland.Job Purpose:
* To ensure that all aspects of global and local computerized systems are implemented and operated in compliance with GxP regulatory requirements and client`s Quality Manuals.
Major Accountabilities:
* Contributes to the client`s cross-functional divisional Computerized System Validation (CSV) committee.
* Contributes to 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 and act as content owner for the client`s Quality Module related to computerized systems.
* 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.
Ideal Background :
Education:
* Graduate in Pharmacy, Chemistry, natural sciences or information technology or several years (> 5) of equivalent experience in pharmaceutical or related regulated industry
Languages:
* English fluent (speaking and writing)
* Command of additional language advantageous
Experience:
* 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.
* 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.
* Operational experience (QA, QC) advantageous
* Knowledge of Quality Systems, Experience in leading a subject matter expert team
* Experience in GCP, SAS, Data management, Data integrity and clinical trials is a must!
Please apply now for more information!