We are currently looking for experienced and motivated expert for the role of IT Quality Manager.
D-ploy is an IT Services and Engineering Solutions company with operations in Switzerland, Germany, Austria, USA, Czech Republic and UK. Since 2003, D-ploy has been offering IT services, knowledge and expertise to our customers across the globe. Our strength is in providing proven standard and individually tailored solutions, helping our customers achieve their strategic and business goals. Our core competencies are consulting and IT services in the area of IT infrastructure, service management, system engineering, migrations and operations.
We are currently looking for experienced and motivated expert for the role of IT Quality Manager. This position is for our client, an international known pharma company. This position is located in Prague, freelances as well as full time employees are equally welcome!
• Understand and adhere to the SOPs on Project Management, Change Management, Document Management and Quality Management; and 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
• 5 years+ relevant work experience in IT/QM compliance.
• Familiar with validation of SAP systems/applications in the past.
• Experience in using SAP solution manager and HPQC testing tools.
• GxP, 21 CFR Part 11, and SOX knowledge as well as SDLC and GAMP knowledge
• Excellent English communication skills, both written and oral, additional languages would be a plus.
• Ability to manage direct relations with stakeholders and project team members. Should have worked in large programs.
• Criminal record is required as part of the background check prior to joining
• Broad range of activities and tasks and projects
• Further development and learning
• Friendly working environment
• Active using of foreign languages
• Competitive salary and various benefits