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 records for GSK's manufacturing sites.
Domain
Pharmaceutical manufacturing / Quality Assurance / Regulatory Compliance
Required skills
Data Integrity, GxP Regulations, Risk Assessment, Technical Writing, Root Cause Analysis, System Validation, CAPA Management, Training & Coaching, Audit Support, Regulatory Inspection Readiness
Preferred skills
Electronic Quality Management Systems, Laboratory Systems, Manufacturing Execution Systems, CSV (Computerised System Validation), IQ/OQ/PQ activities, Lean Management
Technologies
Electronic Quality Management Systems, Laboratory Systems, Manufacturing Execution Systems, Computerised Systems
Responsibilities
Act as Single Point of Contact (SPOC) for data integrity topics; Maintain and drive the site data integrity program; Assess computerised 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
