Specialist QC, QC Systems (Deviations)

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