IT Quality Expert (Regulatory Compliance Platform - Product Supply Quality Assurance Squad)

 

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 (Regulatory Compliance Platform - Product Supply Quality Assurance Squad) 

 

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:

 

• Medical/pharmaceutical/natural science/IT background
• Professional experience (2-3 years) in Quality or GxP related area
• English min. B2/C1 level  written and spoken
• Advanced Microsoft Office (e.g Excel, Word, Power Point)
• Knowledge of regulatory PHARMA requirements: GAMP5, 21 CFR Part 11, EU GMP Annex 11
• Intermediate knowledge and experience in usage of digital collaboration tools (e.g Teams, SharePoint)
• Experience in risk-based and backup/restore validation, cloud systems, change control
• Experience in creating test cases, test protocols, deviation and final reports
• Experience in conducting training, ability to lead and create project plans
• Basic SAP knowledge Basic document management system knowledge
• Familiar with Audit/Risk Management will be beneficial
• Detail-oriented and passionate person with a focus on accuracy, compliance, and completeness in documentation and work results
• Willing to learn and extend skills and knowledge (providing training and leading global teleconferences calls)
• Have communication and collaboration skills, with the ability to work effectively with cross-functional project teams across diverse cultures and geographies
• Have strong organizational skills and ability to work in fast-paced environment and track, coordinate and manage multiple activities while maintaining a high work standars

 

 

What you do:

 

• Perform initial checks of IT supplier quality assessments to evaluate supplier performance and compliance with Bayer quality standards
• 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 and monitor audit activities
• 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 a