Quality Assurance Specialist - QP

Quality Assurance Specialist - QP

Bausch & Lomb

Dublin, Ireland

The QP/Responsible Person, 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.

Responsibilities include but are not limited to:

• 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 BLIL authorisations (WDA, MIA, ASR);
• Ensure processes are maintained in support of BLIL as MAH;
• Manage communications with and represent BLIL in front of HPRA;
• Provide QA expertise to BLIL and manage any Quality issues that arise to closure;
• Support HPRA inspections of BLIL and prepare written responses to inspections;
• Support Bausch + Lomb internal compliance audits of the BLIL 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;
• Perform QP disposition, ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the Member State where certification takes place, in accordance with the Externally Manufactured Products;
• Develop, maintain and approve Quality Agreements in order to ensure that these are current, retrievable and meet the global Bausch + Lomb Quality standards for Quality Agreements;
• Perform Periodic review of QMS and operational procedures for regulatory compliance through an internal audit system;
• Support periodic Management Review meetings;
• Initiate change controls as required;
• Support preparation of and deliver annual GMP and GDP training;
• Communicate with Global B+L colleagues in an effective and timely manner;
• Abide by data integrity requirements at all times.

PERSON SPECIFICATION

• BSc (Hons) in Science or equivalent;
• 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;
• Ability to work on their own initiative and within teams;
• Be able to analyse complex problems and identify solutions;
• Strong communication and organizational skills;
• Excellent ability to deliver results, with strong interpersonal and influencing skills;
• Ability to build relationships internally and externally;
• Trained auditor;
• Available to travel if required to fulfil role.

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