QA Specialist & EU Qualified Person (Hybrid, Dublin)

Bausch & Lomb GmbH; Dublin; Hybrid; EUR 70,000 - 110,000; Full time

Job summary

Bausch + Lomb Ireland Limited is seeking a Quality Assurance Specialist, Responsible Person (RP) to lead the QMS, ensure GMP compliance and act as the qualified person for EU regulations. The role is hybrid with 3 days onsite in City West, Dublin.

The successful candidate will manage QMS activities, CAPA, supplier qualifications and HPRA interactions, driving continuous improvement and regulatory compliance across BLIL operations.

Qualifications

• 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 motivate and influence people.
• Self-starter with ability to prioritize.
• Strong attention to detail and teamwork.

Responsibilities

• Manage the QMS, ensure the QMS is fit for purpose, approve SOPs and Quality System documents.
• Maintain Quality processes in support of BLIL authorizations (WDA, MIA).
• Ensure processes are maintained in support of BLIL as MAH.
• Participate in managing 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.
• Initiate / approve Non-Conformances (NC), CAPA, change controls and complaints.

Skills

Motivation & influence

Self-starter

Prioritization

Attention to detail

Team collaboration

Delivery of results

Education

BSc in Science or equivalent

Job description

Bausch + Lomb Ireland Limited is seeking a Quality Assurance Specialist, Responsible Person (RP) to lead the QMS, ensure GMP compliance and act as the qualified person for EU regulations. The role is hybrid with 3 days onsite in City West, Dublin.

The successful candidate will manage QMS activities, CAPA, supplier qualifications and HPRA interactions, driving continuous improvement and regulatory compliance across BLIL operations.