Job Title: Quality Specialist
The company is seeking a highly skilled Quality Specialist to join their team.
This role will be based at the Little Island site and will be part of the Quality Team.
The successful candidate will be responsible for ensuring effective governance, communication and management systems are in place and maintained.
Main Responsibilities:
* Execution of the Quality Risk Management (QRM) & Site Quality Risk Register (SQRR) processes.
* Execution of the Quality Internal & External Audit/Inspections preparation and management processes for the Site.
* Participation in Site risk assessments.
* Execution of site and quality driven improvement projects as per the site Risk Register.
* Management of projects effectively to meet strict timelines and achieve established milestones.
* Quality Review and Approval of SOPs, Work Instructions and forms from other departments and periodic reviews.
* Responsibility for Gemba Walkdowns & Inspection Readiness Walkdowns from a Quality perspective.
* Quality review and approval of quality non-conformance (NC) records.
* Initiation and ownership of Quality non-conformance records.
Key Skills and Competencies:
* Strong relationship building skills.
* Able to work effectively with teams and individuals.
* Ability to seek opportunities for growth and development professionally.
* Use of best practices to improve business operations.
* Holds self-accountable for compliant and flawless execution.
* Takes personal responsibility for decisions that successfully build customer value.
* Effectively manages and adapts to change.
* Demonstrates integrity and Credo-based actions.
Requirements:
* Third level Degree in a science or pharmaceutical discipline.
* A minimum of 3 to 5 years' experience in a quality or compliance role within the biological and/or pharmaceutical industry.
* Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.