COMPUTER SYSTEMS VALIDATION CONTRACTOR required by CareerWise Recruitment for our BioTech client in Limerick. The COMPUTER SYSTEMS VALIDATION CONTRACTOR uses policies and procedures to validate/qualify computer enterprise systems, including process automation systems, IS applications/infrastructure and enterprise systems.
Role of this position
- Prepares/reviews validation documentation related to projects/change controls.
- Manages change controls and other compliance related tasks e.g. non-conformances.
- Participates in the review of current and future CSV procedures and polices
- Analyzes the results of testing and determines the acceptability of results against predetermined criteria.
- Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
- Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
- Coordinates with and guides other departments or outside contractors/vendors to complete validation tasks.
- Supports regulatory audits and communicates company's computer validation policies.
- Assesses company's computer systems and identifies any potential Part 11 or Annex 11 gaps or Data Integrity.
- Requires BS/BA in Engineering, Chemistry, or Life Sciences with 5+ years of related experience within the fields of Automation and Computer systems and IT Infrastructure Qualification/validation; will substitute relevant experience for education.
- Experience in a GMP environment essential.
- Biologics experience highly desirable
- Experience in Part 11 or Annex 11 or Data Integrity assessment completion
- Experience in Enterprise validation highly desirable
- Knowledge of Infrastructure qualification highly desirable
- Knowledge of Cloud services qualification/validation.
