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IT Quality Senior Expert 

Job purpose: 

To ensure the quality and compliance of suppliers, as well as to support audit readiness and project management for validation and qualification teams. This includes performing and updating supplier quality assessments, providing necessary documentation and evidence for audit scoping and planning, monitoring audit remediation activities, and maintaining audit readiness. Additionally, the activities involve supporting the creation and maintenance of Quality Assurance Agreements, initiating and following up on periodic reviews, and providing project management support to validation and qualification teams to ensure that all processes and documentation meet regulatory and quality standards.

Who you are:

• Bachelor's degree in Medical/pharmaceutical/natural science/IT background
• Professional experience (2-3 years) in Quality or GxP related area
• Experience in conducting training, ability to lead telecofnerences in an international context and to create project plans
• Knowledge of GxP relevant environment
• Familiarity with Audit or Risk Management beneficial
• Advanced Microsoft Office knowledge (e.g Excel, Word,Power Point)
• Intermediate experience in usage of digital collaboration tools (e.g Teams, SharePoint)
• Basic SAP and Veeva Vault environment
• English level B2/C1 written and spoken
• Detail-oriented with a focus on accuracy, compliance, and completeness in documentation and work result
• Willingness to learn and extend skills and knowledge among the team and cooperating with lower/middle management 
• Communication and collaboration skills, with the ability to work effectively with cross-functional project teams across diverse cultures and geographies

What you do:
 

• Perform initial checks of IT supplier quality assessments to evaluate supplier performance and compliance with Bayer quality standards - Veeva Platform
• Update supplier quality assessments based on ongoing performance and compliance evaluations
• Coordinate with cross-functional teams to provide necessary documentation and evidence to support audit scoping and planning
• Monitor audit remediation activities of action plans, tracking progress, and ensuring timely and effective closure of audit findings
• Contribute to the development and enhancement of audit processes and remediation activities to drive continuous improvement
• Maintain audit readiness by keeping System Life Cycle files, incl. IT Quality Validation Master Plan (VMP) up-to-date and aligning with regulatory and compliance requirements
• Monitor external and internal IT framework and compliance requirements to ensure alignment with the IT MS
• Update the IT Management System to reflect changes in processes, standards, and compliance requirements
• Evaluate inspection findings and metrics of the set standards to drive continuous improvement of the IT Management System
• Support the creation and maintenance of Quality Assurance Agreements with suppliers, outlining quality expectations and requirements
• Initiate and follow up on periodic reviews, e.g. access rights, audit trails, services
• Provide project management support to validation and qualification teams, including maintaining project status reports and coordinating project activities
• Track and report the status of all validation and qualification activities, ensuring transparency and alignment with project timelines
• Collaborate with cross-functional teams to support the planning and execution of validation and qualification projects
• Ensure all project documentation is stored in accessible locations, maintaining organization and ease of access for project team members 
• Contribute to continuous improvement initiatives to enhance project management processes and efficiency
• Train, guide, and consult project teams to ensure effective IT system operations and compliant documentation, providing support and expertise to enhance operational efficiency and compliance
• Prepare standardized KPI reporting’s

Location:

Poland : Pomorskie : Gdańsk  

Division:

Enabling Functions 

Reference Code:

847119