QA Specialist II

Gilead

Cork, Ireland

The Position:

This role is a QA Specialist II, permanent role in the GSIUC QA Department, under the QA Supplier systems group. This specific role is required for QA oversight for all GXP Suppliers and Service providers involving External audit Management, QAG Management, External Deviation ownership, approval and coordination, local supplier management involving qualification, approval, and monitoring.

This position requires a sound knowledge of quality assurance systems, methods and procedures. The candidate will be required to exercise judgment, within well-defined and established procedures and practices, to identify problems and appropriate actions and to generate alternatives and recommendations within defined processes. The candidate must be proactive in their daily activities and interactions.

Essential Duties and Job Functions:

Performs a variety of activities to ensure compliance with applicable cGxP regulatory requirements;
Review and Approval of the Introduction of new Suppliers/Service providers and update in scope of approved Suppliers/Service providers i.e change control;
Completion and approval of Qualification review records in the Supplier management system within Gilead QMS to support approval of new supplier/service provider introduction/new material introduction;
Approval of new supplier and material part numbers within Gilead’s product lifecycle management system;
Periodic Evaluation/Continuous monitoring of approved Suppliers/Service provider;
Review of approval of Supplier appraisal reports;
External Audit Management;
Quality agreement Management;
Approval of External Deviations associated with Suppliers/Service providers including full supplier investigations and tracking/trending supplier/material issues;
Coordination of External Deviations associated with Cxo’s;
Completion of yearly Excipient Supplier evaluation including completion of audit frequency assessment and GMP criticality gap assessment review;
Assessment and Approval of Supplier/Service provider Notifications including changes and quality issues;
External and Internal auditing;
Support for regulatory and corporate audits;
Participates in authoring, reviewing, and approving Standard Operating Procedures (SOPs)/other types of controlled documents;
Identifies deviations from accepted practices, exercises judgement to evaluate impact and determines appropriate actions;
Review and approval of GMP Deviation investigations and CAPAs if required;
Performs walkthroughs on behalf of the QA department to ensure site compliance to GMP;
Participates in site Strategic, Technical and Operational Excellence projects on behalf of QA and represents the QA function at relevant cross-functional meetings;
Normally receives very little instruction on routine work, general instructions on new assignments.

Knowledge, Experience and Skills:

Prior experience in pharmaceutical industry is preferred (ideally within a QA role);
Working knowledge of current Good Manufacturing Practices (cGMPs) (FDA/EMEA standards and quality systems);
Demonstrates working knowledge of quality assurance systems, methods, and procedures;
Basic knowledge of OPEX Lean tools, and root cause analysis tools used for identifying and correcting deviations;
Demonstrates audit and investigation skills, and report writing skills;
Good verbal, written, and interpersonal communication skills;
Proficiency in Microsoft Office applications.