The Quality Assurance Manager, QP/RP is a key role at Bausch + Lomb Ireland Limited. The job holder has responsibility for the management and maintenance of BLIL Quality Management System.
This position involves managing the QMS, ensuring it is fit for purpose and making changes as necessary approving SOPs and Quality System documents. The role also involves maintaining quality processes in support of BLIL authorizations (WDA, MIA, ASR) and ensuring processes are maintained in support of BLIL as MAH.
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 the BLIL 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 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.
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.
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 fulfill role.