Beschreibung
Project Qualitiy Managment, GxP, CSV, SOX, FRA, ERES
Responsibilities
-Manages the quality activities for IT projects ensuring compliance with external regulations and internal requirements.
-Collaborates with IT and QA e-Compliance to ensure internal and external regulations are consistently addressed.
-Supports global and regional projects with a variety of compliance impacts (ie GxP, CSV, SOX IT, IT Security, Data Privacy).
-Senior member of project teams working closely with the project manager to plan, organize and create/direct quality activities and deliverables ensuring all relevant compliance requirements are met
-Risk Assessment sessions (FRA, ERES) according the defined procedures and processes ensuring results of the risk assessments are properly applied to associated activities.
-Leads project quality reviews at defined milestones and ensures that all required activities and deliverables have been completed.
-Escalates quality and compliance related issues to IGM Projects Lead/Project Manager/QA e-Compliance or others per applicable policies and procedures
-Supports other related activities such as compliance audits (Health Authorities, SOX IT, Internal Audits), Internal assessments (CSV Periodic Reviews, IT Control Maturity Assessments)
Profile
-University Degree;
-BA/BS in business or technical area or comparable education/experience
-Minimum 3 - 5 years preferably in the Pharmaceutical Industry.
-English fluent written and spoken
If you think you meet the requirements for this position, I look forward to receiving your application through this page.