Job Description
Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the worldfrom the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better. Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries , extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future. This position is based in Dublin working on a hybrid model. The Quality Assurance Manager, QP/RP at Bausch + Lomb Ireland Limited has responsibility for the management and maintenance of BLIL Quality Management System. Furthermore, the job holder is acting as qualified person as per EU GMP and responsible person as per EU GDP requirements. KEY RESPONSIBILITIES: 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 authorizations (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. 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 theBLILQuality 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 BLIL 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. The RP must be eligible to act as EU GDP responsible person as per EU GDP guideline. PERSON SPECIFICATION BSc (Hons) in Science or equivalent. QP/RP 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. Ability to work on their own initiative and within teams. Be able to analyse complex problems and identify solutions. Strong communication and organizational skills. Leadership 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. Benefits: Work From Home