Kneat Validation Systems Administrator

Our Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around the Impact You Will MakeThis exciting new position at Kindeva! This role is responsible for the day-to-day administration and configuration of the Kneat eValidation system across all Kindeva sites. The Kneat Validation System administrator creates updates and maintains templates workspaces disciplines and document types within Kneat to support site validation activities. Working under the direction of the leader this role ensures the system is configured correctly users are supported and records are maintained in compliance with GxP requirements and internal ResponsibilitiesCreate update and modify Kneat templates document types and document packs for all Kindeva sites ensuring they reflect current SOPs and validation up and maintain workspaces and disciplines in Kneat for all Kindeva sites configuring site-specific settings and ensuring correct workspace structure for each user management activities including account creation role assignments access modifications and periodic access reviews for all Kindeva site and document validation lifecycle activities (IQ/OQ/PQ protocol execution discrepancy management and summary reports) using Kneat workflows under guidance from the validation day-to-day end-user support and troubleshooting for Kneat configuration issues document routing problems and execution queries across all Kindeva Kneat system release updates by reviewing release notes assisting with validation impact assessments executing regression testing and documenting with Quality IT Engineering and Manufacturing teams to ensure compliant system use and alignment with SOPs and validation in training and onboarding users in Kneat functionality and best practices for compliant experience is a plus with exposure to supporting multiple clients projects or validation strategies within Kneatsupported inspection readiness activities by ensuring Kneat records audit trails and system documentation are complete and system compliance with GxP 21 CFR Part 11 EU Annex 11 and other applicable with cross-functional teams to understand requirements and translate them into system solutions. Collaborate with cross-functional teams to understand requirements and translate them into system solutions. Support quality processes such as Change Control CAPA Deviations Complaints and Document Management. Participate in cross-functional governance meetings and harmonization initiatives as informed on Kneat system updates new features and relevant regulatory guidance under the direction of the Kneat in the delivery of Kneat user training and onboarding for new users across Kindeva sitesCoordinate draft test cases and test Kneat releases and updates including owning the associated change controls. Monitor system performance and troubleshoot issues. Maintain documentation for system configuration and validation data integrity backup and disaster recovery protocols are in system logs and security alerts; implement corrective actions as 8 years of experience in validation quality systems in the pharmaceutical medical device or biotechnology industryBachelors or Masters degree preffered in Engineering Life Sciences Pharmacy or related field .Hands-on experience with the Kneat eValidation platform including template creation workspace configuration and user background in all disciplines of validation (i.e. equipment computer AIQ process)Excellent problem-solving communication and organizational skills. Ability to work independently and in a global cross-functional team on experience with GMP computerized systems including system validation and regulatory compliance. Working knowledge of GMP computerized systems 21 CFR Part 11 and EU Annex 11 requirements in a regulated manufacturing admin certification preferred (or willingness to obtain upon hire)Familiarity with GMP regulatory requirements and the importance of data integrity in a validated#LI-Remote#JJ