Cork city, Ireland | Posted on 12/05/2025
Industry Pharma/Biotech/Clinical Research
Work Experience 4-5 years
City Cork city
State/Province Cork
Country Ireland
Job Description
PSC is hiring in Cork
We are looking for a
Quality Specialist (Risk Management)
to join our Quality Team.
This role is responsible for overseeing
Quality Risk Management
and ensuring
Quality Systems compliance
for UC, in accordance with
Good Manufacturing Practice (GMP)
Responsibilities
Execution of the Quality Risk Management (QRM) & Site Quality RiskRegister (SQRR) processes ensuring effective governance, communication and management systems are in place and maintained.
Execution of the Quality Internal & External Audit/Inspection 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 RiskRegister e.g. but not limited to,
Supplier Qualifications.
Reclassification of plant areas.
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
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.
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