Beschreibung
Project Manager - Computer System Validation
Job Responsibilities:
- Understand and adhere to the SOPs on Project Management, Change Management, Document Management and Quality Management; and Novartis Group Computerized System Validation concept with regards to document management.
- Support project managers on the application of the project methodology
- Driving achievements of the Validation/Quality goals by ensuring that the process and standards defined for the project are followed
- Escalating project quality issues to project team & Program PQM
- Along with the project manager, prepare and reply to project-related CSV or audits, assessments or inspections where applicable
- Supporting PM in risk management activities
- Along with the project manager, participate and document project handover to operations
- Change management from quality manager role perspective
- Create/review and approve high level project deliverables (project management and quality management)
- Record project-originated GxP deviations where applicable
- Reviewing and managing test deviations from compliance perspective
- Train and coach the project team, as required, on relevant project procedures, good documentation practice, good testing practice and CSV basics, where applicable
Education/Experience:
- 5-8 years' relevant work experience in IT/QM compliance.
- Excellent English communication skills, both written and oral, additional languages would be a plus.
- Able to manage direct relations with stakeholders and project team members. Should have worked in large programs.
- GxP, 21 CFR Part 11, and SOX knowledge
- SDLC and GAMP knowledge
Mandatory Skills
Computer system validation, GxP, 21 CFR Part 11, Excellent communication
Good to Have Skills
Data privacy, IT security