Beschreibung
Für unseren Kunden suchen wir zum nächstmöglichen Zeitpunkt in freiberuflicher Tätigkeit eine/n IT Consultant PMO (m/w) in Holzkirchen.Laufzeit: 6 Monate
Einsatzort: Holzkirchen
Auslastung: 100 %
Start: ASAP
Ihre Aufgaben:
• 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
Ihr Profil:
• 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
Sollten Sie uns bei diesem Projekt unterstützen können, so bitten wir um die Zusendung geeigneter Profile an
Vielen Dank im Voraus.
Marjan Wali
Recruiting Assistant
Infoplus Technologies GmbH
Kastor & Pollux - Platz der Einheit 1
D - 60327 Frankfurt Am Main
Tel:
Fax: