QP

A 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 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.

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 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.


REQUIREMENTS:

•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.


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.

By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.