Computer System Validation Professional For Confidance® Validation Services

Computer System Validation CSV Professional Join Sartorius as a Senior Computer System Validation CSV Professional and become a key player in driving harmonization compliance and quality assurance within our Confidence Validation Services Quality team In this impactful role you will lead the establishment of a harmonized validation policy ensuring our computer systems are compliant with the latest regulatory standards e g 21 CFR Part 11 OECD 17 OECD 17 supplement 1 EU-GMP Annex 11 Your expertise will be instrumental in implementing state-of-the-art tools such as an eQMS and ELN LIMS enhancing our service department s efficiency and quality Additionally you will have a chance to elevate our quality assurance processes by driving the implementation of an eQMS as well as to contribute to the global harmonization across all Confidence Validation Services sites This full-time hybrid position offers the flexibility of remote work while requiring some on-site presence to foster collaboration and innovation Your Key Responsibilities Lead the Development and Implementation Spearhead the creation and execution of a comprehensive computer system validation policy ensuring alignment with current regulatory standards e g 21 CFR Part 11 OECD 17 OECD 17 supplement 1 EU-GMP Annex 11 GAMP 5 for Confidence Validation Services Drive Global Electronic Systems Initiatives Lead the implementation of new global electronic systems such as an eQMS ensuring seamless integration and compliance Post-Implementation Manage the ongoing maintenance and updates of electronic systems ensuring optimal performance and compliance Risk Assessment and Compliance Conduct risk assessments compile compliance reports manage deviations and ensure all documentation meets quality and regulatory standards Create and oversee CSV protocols including IQ OQ and PQ ensuring thorough validation of electronic systems Oversee the document lifecycle from creation and revision to storage Support administration of electronic systems ensuring efficient operation Offer basic CSV training to enhance team capabilities and ensure compliance Collaborate intimately with all stakeholders to guarantee systems comply with project and regulatory standards Participate in regular project meetings to align with system owners and management ensuring project requirements are met and issues are resolved Supervise vendor interactions including reviewing and tracking vendor deliverables and system qualifications Collaborate with global regional site quality units and functions to ensure harmonized practices Any ad hoc duties to collaborate and contribute to other activities as identified Confidence management What will convince us Advanced Educational Background Master s degree or higher in a relevant field e g Engineering Computer Science Life Sciences Industry Experience Minimum of 5 years in a GMP and or GLP-regulated environment with a proven track record in validating cloud solutions such as eQMS LIMS ELN and stand-alone computer systems Regulatory Expertise Extensive knowledge of CSV regulatory requirements e g 21 CFR Part 11 OECD 17 OECD 17 supplement 1 EU-GMP Annex 11 GAMP 5 Independent Deliverable Generation Ability to independently generate CSV deliverables ensuring high-quality outputs Experience in working in a cross-cultural set up Ability to develop realistic work plans set personal goals that align with company goals Superior organizational communication and documentation skills Self-driven and methodical way of working ensuring thoroughness and accuracy Fluent in English with excellent communication skills About Sartorius Sartorius is part of the solution in the fight against cancer dementia and many other diseases Our technologies help translate scientific discoveries into real-world medicine faster so that new therapeutics can reach patients worldwide We look for ambitious team players and creative minds who want to contribute to this goal and advance their careers in a dynamic global environment Join our global team and become part of the solution We are looking forward to receiving your application