Quality Assurance Manager
3 days ago
Bausch + Lomb Ireland, a leading global eye health company, is seeking an experienced Quality Assurance Manager to join its team in Dublin.
The ideal candidate will have a strong background in quality assurance, with a minimum of 5 years of experience working in the healthcare industry. They will be responsible for managing the company's Quality Management System (QMS), ensuring compliance with regulatory requirements, and maintaining relationships with external stakeholders such as the Health Products Regulatory Authority (HPRA).
The successful candidate will have excellent communication and organizational skills, with the ability to analyze complex problems and identify solutions. They will also have leadership skills and the ability to work independently and as part of a team.
Key Responsibilities:
- Manage the QMS, ensuring it is fit for purpose and compliant with regulatory requirements.
- Maintain quality processes in support of Bausch + Lomb Ireland's authorizations.
- Ensure processes are maintained in support of Bausch + Lomb Ireland as a Marketing Authorization Holder (MAH).
- Manage communications with and represent Bausch + Lomb Ireland in front of HPRA.
- Provide QA expertise to Bausch + Lomb Ireland and manage any quality issues that arise to closure.
Required Skills and Qualifications:
- BSc (Hons) in Science or equivalent.
- QP/RP qualification.
- Thorough working knowledge of Good Distribution Practice (GDP) and regulatory expectations for medicinal products.
- Minimum of 5 years of experience working in Quality Assurance in the Healthcare Industry.
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