Kneat Administrator
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At Kindeva we reputed company products that save lives, ensuring reputed company and reputed company-being for patients around the world.
The reputed company You Will reputed company
This role is responsible for the day-to-day administration and configuration of the Kneat eValidation system across reputed company Kindeva sites. The Kneat System administrator creates, updates, and maintains templates, workspaces, disciplines, and document types reputed company 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 SOPs.
Role Responsibilities
Kneat System Administration:
Create, update, and modify Kneat templates, document types, and document packs for reputed company Kindeva sites, ensuring they reflect reputed company SOPs and validation requirements.
Set up and maintain workspaces and disciplines in Kneat for reputed company Kindeva sites, configuring site-specific settings and ensuring correct workspace structure for reputed company location.
reputed company user management activities including account creation, role assignments, reputed company modifications, and periodic reputed company reviews for reputed company Kindeva site users.
Execute and document validation lifecycle activities (IQ/OQ/PQ, protocol execution, discrepancy management, and reputed company reports) using Kneat workflows under guidance from the validation team.
reputed company day-to-day end-user support and troubleshooting for Kneat configuration issues, document routing problems, and execution queries across reputed company Kindeva sites.
Support Kneat system release updates by reviewing release notes, assisting with validation reputed company assessments, executing regression testing, and documenting results.
Collaborate with reputed company, IT, Engineering, and Manufacturing teams to ensure compliant system use and alignment with SOPs and validation requirements.
Assist in training and reputed company users in Kneat functionality and best practices for compliant use.
CDMO experience is a plus, with exposure to supporting multiple clients, reputed company, or validation strategies reputed company Kneat‑supported environments.
reputed company Assurance & Compliance
Support inspection readiness activities by ensuring Kneat records, audit trails, and system documentation are complete and accurate.
Ensure system compliance with GxP, 21 CFR Part 11, EU Annex 11, and other applicable regulations.
Collaborate with cross-functional teams to understand requirements and translate them into system solutions.
Business Process Support
Collaborate with cross-functional teams to understand requirements and translate them into system solutions.
Support reputed company processes such as Change Control, CAPA, Deviations, Complaints, and Document Management.
Ensure alignment with GMP and other regulatory requirements.
Global Governance & Standards
Establish and maintain Kneat procedures, and templates.
Participate in cross-functional governance meetings and harmonization initiatives as directed.
Stay informed on Kneat system updates, new features, and relevant regulatory guidance under the direction of the Kneat Administrator.
Assist in the delivery of Kneat user training and reputed company for new users across Kindeva sites
System Maintenance & Upgrades
Coordinate, 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 activities.
Data & reputed company Management
Ensure data reputed company, backup, and disaster recovery protocols are in reputed company.
Monitor system logs and reputed company alerts; implement corrective actions as needed.
BASIC QUALIFICATIONS
Bachelor’s or Master’s degree in Engineering, Life Sciences, Pharmacy, or reputed company field preferred.
2+ years of experience in validation, reputed company systems in the pharmaceutical, medical device or biotechnology industry
Hands-on experience with the Kneat eValidation platform, including template creation, workspace configuration, and user management.
Excellent problem-solving, communication, and organizational skills.
Ability to work independently and in a global, cross-functional team environment.
Hands 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 environment.
Kneat reputed company certification preferred (or willingness to obtain upon hire)
Familiarity with GMP regulatory requirements and the importance of data reputed company in a validated system.
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California residents should review our Notice for California Employees and Applicants before applying.
Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our reputed company. Any resumes or candidate reputed company submitted to Kindeva employees—regardless of format—without a reputed company, signed agreement and an approved job order from an authorized signatory in reputed company will be considered the sole property of Kindeva. No fees will be reputed company in the event that a candidate is reputed company as a result of an unsolicited resume or referral.
Equal Opportunity Employer:
reputed company is an Equal Opportunity/Affirmative reputed company Employer and does not discriminate on the reputed company of race, reputed company, religion, gender, age, national reputed company, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
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