Data Integrity Specialist
Core
Lead data integrity activities to protect the completeness, accuracy, and availability of quality and manufacturing data in a pharmaceutical setting.
Role type
Data Integrity Specialist (Pharmaceutical Quality)
Builds
Data integrity programs, validated computerized systems, and compliant paper/electronic records.
Domain
Pharmaceutical manufacturing and quality compliance
Required skills
Data Integrity, GMP principles, Computerized System Validation (CSV), Risk Assessment, Root Cause Analysis, Technical Writing, CAPA management, Audit support, Training & Coaching, Regulatory Compliance
Preferred skills
Electronic Quality Management Systems, Laboratory Systems, Manufacturing Execution Systems, IQ/OQ/PQ activities, Data Integrity Audits
Technologies
Electronic Quality Management Systems, Laboratory Systems, Manufacturing Execution Systems
Responsibilities
Act as Single Point of Contact (SPOC) for data integrity topics; Maintain and drive the site data integrity program; Assess computerized systems and paper records for data integrity risk; Write, review, and approve procedures and training materials; Lead investigations of data integrity issues and support CAPA; Deliver training and coaching for site colleagues; Participate in internal audits and support readiness for regulatory inspections.
Seniority
Mid-level, hands-on IC
