QA Specialist

Desired Skills: quality assurance,sterile operations,aseptic processing

Description:

PE Global is currently recruiting for a QA Specialist on behalf of a leading pharmaceutical company based in Cork. This is an initial 12-month contract role.

Overview:

The position will be part of the Quality Team. This position is responsible for Quality Risk Management and Quality Systems compliance activities as required by Good Manufacturing Practice (GMP).

Responsibilities:

• 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.
• 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.

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.
• Experience with data integrity as a QA Specialist
• Experience with risk management projects and driving improvements.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***