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Lead Validation Engineer
2 months ago
Company: Katalyst HealthCares & Life Sciences
Key Responsibilities:
- Engage in multiple roles across diverse systems including SDMS, Labx, Veeva RIM, ValGenesis, and Labware LIMS.
- Conduct thorough risk evaluations pertaining to Data Integrity.
- Examine discrepancies and implement corrective actions within CGMP operations.
- Perform compliance assessments for Data Integrity and prepare comprehensive executive summary reports.
- Work collaboratively with both internal and external stakeholders to evaluate the maturity of Data Integrity practices.
- Possess a strong understanding of GMP standards and current quality trends.
- Demonstrate the ability to independently troubleshoot issues and finalize system qualifications within established parameters.
- Exhibit expertise in system qualification, application validation, and adherence to regulatory standards.
- Hold a Bachelor's degree in a scientific or engineering field along with relevant experience.
- Have a background in pharmaceutical application systems that support laboratory and production environments.
- Possess experience in validation protocols for computer systems.
- Ability to create various deliverables and protocols throughout the system life cycle.
- Proficient in utilizing MS Office applications.
