What are the responsibilities and job description for the Data Integrity / CSV Consultant position at Synergy Bioscience?
As a DI / CSV specialist, you will be working as part of the Quality Validation team strengthening the compliance of the quality system for all Data Integrity aspects including Computer systems validation.
Assists in DI / CSV improvement projects and acts as an SME regarding Data Integrity. The DI / CSV person will drive the improvement efforts and also be involved in all quality-related responsibilities for automation and Computerized System Validation (CSV ).
The DI / CSV specialist will work with cross-functional groups to build data integrity principles into paper-based and computer system-based life cycles. This role will work to get a deep understanding of the GMP Data Flows and apply data integrity principles to ensure regulatory compliance.
Key responsibilities :
- Support operations and projects for Data Integrity Requirements to align with overall data integrity governance
- Be a Subject Matter Expert and provide technical support for all aspects of Data Integrity supporting CSV activities
- Oversee and guide operations and projects in aspects of Data Integrity
- Complies with GMP regulations with a focus on data integrity. Performs activities required to mitigate any compliance gaps identified
- Support data integrity training content / tracking and training for site personnel
- Collaborate in the gathering, tracking, and reporting of data integrity metrics
- Collaborate with cross-functional teams on aspects of Data Integrity
- Support mitigation and remediation efforts for data integrity compliance across the site
- Perform, facilitate, and support data integrity improvements for documents, processes, and equipment
- Review and approve validation documentation, risk assessments, and support in site compliance activities
- Responsible for ensuring the Data Integrity Compliance of standard operating procedures and work instructions across the site
- Support the change control process with respect to the data integrity impact, able to assess the change controls with respect to data integrity
- Participate in deviations related to data integrity
- Experience with Current Good Manufacturing Practices and Good Documentation Practices
- Participate in gap assessments to ensure regulatory findings at the company and in the industry are monitored and corrected.
- Support quality-related responsibilities for automation and Computerized System Validation (CSV)
- Representing Quality in the respective global standards definition and implementation.
Key requirements :
