IT Systems Validation Specialist
1 month ago
IT Systems Validation Specialist
Key Responsibilities:
- Develop project validation plans and generate summary reports to ensure compliance with regulatory requirements.
- Evaluate risk assessment and functional requirements specifications to identify potential issues.
- Act as liaison between quality assurance and project teams to facilitate effective communication.
- Drive each phase of the project lifecycle, including requirements gathering, risk assessment, and change management.
Requirements:
- Bachelor's degree in business or IT or comparable education and experience.
- Minimum 5 years of experience in computer systems validation, including authoring and executing IOQ/PQ's and strong familiarity with cGMP/GLP/GAMP5/GALP.
- Familiarity with all phases of a systems development life cycle.
- Proficiency in SAP, LIMS, and Empower is an asset.
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