Job Title: Quality Specialist (Data Integrity/Risk Management)
Location: Little Island, Cork IRL T45 P663
Duration: 12 months
Notes:
* They need experience with data integrity as a QA Specialist, and this must be demonstrated in the application.
* They also need experience with risk management projects and driving improvements.
* Need pharma background
Position Summary:
* The position will be located at the Little Island site and will be part of the Quality Team.
* This position is responsible for
Quality Risk Management and Quality Systems compliance
activities related to Client as required by Good Manufacturing Practice (GMP).
Main duties and responsibilities:
The key elements of the role can be broken down into the following clusters:
* Execution of the Quality Risk Management (QRM) & Site Quality Risk Register (SQRR) processes ensuring effective governance, communication and management systems are in place and maintained.
* Execution of the Quality Internal & External Audit/Inspections preparation and management processes for the Site (including follow up on audit action completion, associated CAPA's, and NC Quality approval).
* Participate in Site risk assessments.
* Execute site and quality driven improvement projects as per the site Risk Register e.g. but not limited to, Supplier Qualifications, Reclassification of plant areas and Site Data Integrity Program
* Manages projects effectively to meet strict timelines and achieve established milestones with regular updates to Quality and Site Leadership Teams.
* Quality Review and Approval of SOPs, Work Instructions and forms from other departments and periodic reviews.
* Responsible for Gemba Walkdowns & Inspection Readiness Walkdowns from a Quality perspective.
* Quality review and approval of quality non-conformance (NC) records. Quality point of contact for attendance at Root Cause Analysis meetings.
* Initiation and ownership of Quality non-conformance records.
* Quality assessor, reviewer and approval of quality non-conformance (NC) records.
Key Skills and Competencies required:
* Builds strong productive relationships.
* Demonstrates ability to work with teams and individuals.
* Seeks opportunities to grow and develop professionally.
* Uses 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.
* Always demonstrate Integrity and Credo-based actions.
Education and Experience:
* 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.