Quality Manager / QP

A QA Manager / QP is required on a PERMANENT basis by CareerWise Recruitment for our Dublin based Healthcare Client.

This position is based on a hybrid model.

The Quality Assurance Manager, QP has responsibility for the management and maintenance of the Quality Management System. Furthermore, the job holder is acting as QP as per EU GMP and responsible person as per EU GDP requirements.

THE ROLE:

• Manage the QMS, ensure the QMS is fit for purpose, making changes as necessary approving SOPs and Quality System documents.
• Maintain Quality processes in support of authorizations (WDA, MIA, ASR)
• Ensure processes are maintained in support of company as MAH
• Manage communications with and represent company in front of HPRA.
• Provide QA expertise and manage any Quality issues that arise to closure.
• Support HPRA inspections and prepare written responses to inspections.
• Support internal compliance audits of operations.
• Prepare and approve HPRA variations.
• Provide QA oversight and expertise for New Product Introductions
• Review and approve Non-Conformances (NC), CAPA, change controls and complaints.
• Ensure annual review of supplier and customer bona fides to verify compliance with Guidelines on Good Distribution Practice.
• Ensure Batch record review to verify compliance with GMP and Market Authorization prior to batch release.
• Review, and where appropriate, preparation and regular update of technical agreements with licensees and 3rd party contractors.
• Regular presentation and review of intercompany Quality service provider performance against measures relating to the Quality Objectives at periodically held Quality Operations meetings.
• Periodic review of QMS and operational procedures for regulatory compliance through internal audit system.
• Scheduling periodic Quality Operations management review meetings with third parties, annual Quality Management Review meetings, and preparing the agenda and minutes for both meetings.
• Attending the annual Quality Management Review meeting and participating in the review of the Quality and Regulatory Compliance Policy and Objectives for continuing suitability.
• Implementation of the Self Inspection/Internal Quality Audit program.
• Overall responsibility for reporting and investigation of non-conformances and identification of CAPAs to ensure continuous improvement of the QMS and operational procedures.
• Escalation of issues as appropriate.


The QP must be eligible to act as a European Qualified Person (QP), certifying products in compliance with 2001/83/EC, 2003/94/EC and Annex 16.

REQUIREMENTS:

• BSc (Hons) in Science or equivalent
• QP qualification
• Thorough working knowledge of GMDPs and regulatory expectations for medicinal products and medical devices
• Minimum of 5 years of experience working in Quality Assurance in the Health Care Industry
• Trained auditor
• Available to travel if required to fulfil role


Please call Aisling O’Hagan-Yil today for further information on 021- 2427410 or email: aohagan-yil@careerwise.ie

CareerWise Recruitment (In Search of Excellence)

Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

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