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 Senior/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 backgroundProfessional 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 will be an asset

 

What you do:
 

Coordinate with cross-functional teams to provide necessary documentation and evidence to support audit scoping and planningMonitor audit remediation activities of action plans, tracking progress, and ensuring timely and effective closure of audit findingsContribute to the development and enhancement of audit processes and remediation activities to drive continuous improvementMaintain audit readiness by keeping System Life Cycle files, incl. IT Quality Validation Master Plan (VMP) up-to-date and aligning with regulatory and compliance requirementsMonitor 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 requirementsEvaluate inspection findings and metrics of the set standards to drive continuous improvement of the IT Management SystemSupport the creation and maintenance of Quality Assurance Agreements with suppliers, outlining quality expectations and requirementsInitiate and follow up on periodic reviews, e.g. access rights, audit trails, servicesProvide project management support to validation and qualification teams, including maintaining project status reports and coordinating project activitiesTrack and report the status of all validation and qualification activities, ensuring transparency and alignment with project timelinesCollaborate with cross-functional teams to support the planning and execution of validation and qualification projectsEnsure 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 efficiencyTrain, 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
   YOUR APPLICATION   

Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below. 

Bayer offers the possibility of working in a hybrid model. We know how important work-life balance is, so our employees can work from home, from the office or combine both work environments. The possibilities of using the hybrid model are each time discussed with the manager.
 

     Location:Poland : Pomorskie : Gdańsk    Division:Enabling Functions   Reference Code:825580   

 

 

Location:

Poland : Pomorskie : Gdańsk  

 

Division:

Enabling Functions 

 

Reference Code:

825580