Compliance consultant - Katalyst Healthcares & Life Sciences
Parsippany, NJ 07005
About the Job
Responsibilities:
- Lead the development and execution of validation protocols for SAP implementation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Create comprehensive validation strategies and summary reports to document the qualification process and results for the SAP platform.
- Review and provide guidance on test scripts and testing guidelines to ensure thorough and compliant SAP system testing.
- Collaborate with cross-functional teams to understand GxP business requirements and prioritize them in the validation process.
- Assess and ensure that the SAP system meets SOX/Financial controls and high-level testing requirements, maintaining compliance with all relevant regulations.
- Proven experience in computer system validation with a focus on SAP implementation.
- Strong understanding of GxP requirements and the ability to integrate them into the validation process effectively.
- Knowledge of SOX/Financial controls and the ability to ensure that testing meets these high-level requirements.
- Demonstrated ability to develop validation protocols and summary reports, ensuring comprehensive coverage and compliance.
- Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams and stakeholders.
Source : Katalyst Healthcares & Life Sciences