19441-QA Specialist-Tipperary Contractor

This is an 11-month contract initially and is a hybrid position.

Purpose:

The Quality Associate Specialist/ Specialist will provide Quality oversight, support and knowledge to activities relating to Quality Systems across the site and in meeting the Company Priorities of: Compliance, Supply, Strategy and Profit Plan

Responsibilities:

• Provides to the site knowledge and experience in Quality Systems and/or Operational Quality, including the following i.e. Quality Notifications/ Investigations/LIR coaching; GCM coaching, environmental monitoring program, sterility assurance/low bio-burden manufacturing, customer complaint investigations etc.

• Uses knowledge to improve Quality Systems, solve problems, provide continuous improvement and execute tasks.

• Provides compliance contribution to project teams and leads small projects.

• May coach and guide colleagues within the site.

• Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.

• Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.

• Supports Corporate Quality to ensure actions related to Quality Systems and/or Operational Quality at the site are executed.

• Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow-up actions where applicable.

• Ensure supply of high-quality products through the implementation and oversight of the Quality Management System for the site.

• Ensure the highest Quality, Compliance, and Safety standards.

• The  Associate Specialist/ Specialist will participate and comply with the Quality Management System (QMS) requirements, including ownership.

• Responsible for driving a culture of Continuous Improvement by deploying Six Sigma tools within across operational areas.

• The Quality Associate Specialist/ Specialist will have proven capability in the development of Quality Systems as an active member, across cross-functional teams, to deliver process improvement. Model the Leadership behaviours and understand the MPS principles to drive a culture of continuous improvement building a High-Performance Organisation

Requirements:

• Degree or 3rd level qualification (Science, Quality)

• 1 – 5 years experience in the pharmaceutical industry or a similar operating environment which includes experience in a Quality function

• Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (i.e. Quality, science, etc.)

• Operational experience of at least 4 QMSs