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Job Description
Seeking a QP to manage the QMS, ensuring compliance with EU regulations and overseeing quality processes for a Dublin-based healthcare client.
The QP/Responsible Person will be responsible for:
- Managing the QMS, ensuring it is fit for purpose and making changes as necessary
- Approving SOPs and Quality System documents
- Maintaining quality processes in support of BLIL authorisations (WDA, MIA, ASR)
- Ensuring processes are maintained in support of BLIL as MAH
- Managing communications with and representing BLIL in front of HPRA
- Providing QA expertise to BLIL and managing any quality issues that arise
- Supporting HPRA inspections of BLIL and preparing written responses to inspections
- Supporting Bausch + Lomb internal compliance audits of the BLIL operations
- Preparing and approving HPRA variations
- Providing QA oversight and expertise for New Product Introductions
- Reviewing and approving Non-Conformances (NC), CAPA, change controls and complaints
- Performing QP disposition, ensuring each individual batch has been manufactured and checked in compliance with laws in force in the Member State where certification takes place
- Developing, maintaining and approving Quality Agreements
- Performing periodic review of QMS and operational procedures for regulatory compliance through an internal audit system
- Supporting periodic Management Review meetings
- Initiating change controls as required
- Supporting preparation of and delivering annual GMP and GDP training
- Communicating with Global B+L colleagues in an effective and timely manner
- Abiding 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
- Ability 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