Career Category
Quality
Job Description
ADL QC Systems (Deviations), Specialist QC
Overview:
This job specification outlines the general responsibilities associated with the role of Specialist QC, QC Systems (Deviations) at Amgen Dun Laoghaire. The QC Systems team provide support to the QC function for all activities within Amgen’s Quality System associated with QC Deviation Investigations, CAPA records, Testing Results Assessments (TRA) and Change Controls
The successful candidate will join the investigations team as a senior member of the team. Continuous Improvement with regard to investigations and error management will be key areas of focus for the role.
Additionally, the role may involve carrying out additional work functions that are not described in this specification but are associated with the QC support function.
Key Responsibilities
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. Escalates as required.
Knowledge and Experience:
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 advantageous
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Salary Range
67,993.20 EUR - 91,990.80 EUR