What are the responsibilities and job description for the Data Integrity Specialist position at Virtual Synergie Solutions?
Our client is hiring for a Data Integrity support specialist for electronic and paper-based systems.
Responsibilities: Duties will include authoring standard operating procedures, creating data maps for laboratory and manufacturing systems, and assisting site staff in adherence to national and international regulatory guidelines on Electronic Records and Electronic Signatures and Data Integrity, cGMP, FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA and GAMP5 guidelines.
- Research Laboratory and Manufacturing processes to develop compliance gap assessments.
- Understand Laboratory and Manufacturing data lifecycles to develop data maps.
- Report on progress of data integrity work and significance of the results
- Assist Laboratory and Manufacturing personnel with development of procedures, job aids and other documentation to improve the overall site compliance stance
Requirements
- Experience reviewing/authoring standard operation procedures
- Proficiency with core computer software/systems (Microsoft Word, Excel, SharePoint, Project, etc.)
- Experience with computerized systems attached in a cGMP environment a plus
Job Type: Full-time
Pay: $75,000.00 - $85,000.00 per year
Benefits:
- Health insurance
Schedule:
- Monday to Friday
Education:
- High school or equivalent (Preferred)
Experience:
- reviewing/authoring standard operation procedures: 3 years (Required)
- (Microsoft Word, Excel, SharePoint, Project, etc.): 3 years (Required)
- in a cGMP environment: 3 years (Preferred)
Work Location: One location
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