Specialist QC, QC Systems (Deviations)

Career Category

Quality

Job Description

ADL QC Systems (Deviations), Specialist QCOverview:

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