IT Quality Expert

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

IT Quality Expert 

Purpose of the role:

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


• Familiarity with Audit or Risk Management beneficial


• Knowledge of GxP relevant environment


• Detail-oriented with a focus on accuracy, compliance, and completeness in documentation and work result


• Willingness to learn and extend skills and knowledge


• Communication and collaboration skills, with the ability to work effectively with cross-functional project teams across diverse cultures and geographies


• Motivated to share knowledge and support colleagues


• Digital knowledge within Microsoft Office (e.g Excel, Word), experience in usage of digital collaboration tools (e.g Teams, SharePoint), basic SAP knowledge


• Basic document management system knowledge


• English level B2/C1


• German level B2/C1

What you do:

• 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:

870283