Specialist QC, QC Systems (Deviations)

• Champion for Investigations in Quality Control
• Owns and Manages Investigations for QC through DQMS
• Authors and reviews investigation reports
• Participates routinely in the investigation triage process
• Ensures investigations are kept up to date and compliant with procedures
• Ensure investigations result in robust CAPA to prevent recurrence
• Seeks out opportunity to improve the process and management of Investigations
• Error Management Champion, SME for error management and error reduction in QC
• Lead improvement initiatives as required e.g. Predict, Prevent, Improve (PPI)
• Strong focus on RFT and Lean
• Key contact for Investigation Metrics
• Provides coaching, support and mentoring on investigations to the investigation team
• Builds relationships and partners with similar roles at ADL and in the network to share lessons learned and improvements
• May own Change Controls linked to investigations and CAPAs
• May provide support for Protocol generation linked to QC Investigations
• Supports Audits and Inspections with regard to preparation and participation
• Represents QC at site and network level with regard to Investigations
• Works with minimal supervision but knows when to escalate or look for support
• May co-ordinate the Investigation team workload such that investigations are prioritized as required and delivered within due dates

• Hold a third level qualification in science related discipline
• Have minimum 6 years’ experience in Biotechnology/ Pharmaceutical setting
• Possess key competencies to include Planning and Organisation, Communication, Teamwork, Flexibility and Adaptability
• Excellent Technical Writing skills
• Proficient in Root Cause Analysis
• Detailed knowledge of the QC function and is operationally savvy
• Proven Experience of handling GMP investigations within a Quality System
• Demonstrated Leadership attributes: Delivers Results

Knowledge of Error Management Methodologies and experience with Six Boxes Approach