EU QP & Quality Assurance Specialist - Hybrid Dublin

Bausch & Lomb GmbH; Dublin; Hybrid; EUR 85,000 - 120,000; Full time

Job summary

Bausch + Lomb Ireland Limited is seeking a Quality Assurance Specialist who will act as a Responsible Person (RP) with European Qualified Person eligibility. The role requires managing the QMS, ensuring GMP compliance, and supporting regulatory submissions and inspections in a hybrid Dublin setting.

The successful candidate will lead QA activities, coordinate CAPAs, oversee supplier and product compliance, and partner with HPRA to maintain regulatory readiness. Available travel may be required.

Qualifications

• BSc (Hons) in Science or equivalent.
• Thorough working knowledge of GMP/Regulatory expectations for medicinal products and medical devices.
• Minimum of 5 years of QA experience in Health Care industry.
• Ability to motivate and influence people; strong prioritization and initiative.
• Good teamwork with strong communication and problem-solving skills.

Responsibilities

• Manage the QMS to ensure it remains fit for purpose and document changes.
• Support BLIL authorizations (WDA, MIA) and MAH activities.
• Represent BLIL in communications with HPRA and during inspections.
• Provide QA oversight for New Product Introductions and CAPA programs.
• Initiate/approve Non-Conformances and change controls; track corrective actions.
• Review batch records to ensure GMP compliance prior to release.

Skills

Motivation & influence

Self-starter

Initiative

Attention to detail

Interpersonal skills

Education

BSc (Hons) in Science

Job description

Bausch + Lomb Ireland Limited is seeking a Quality Assurance Specialist who will act as a Responsible Person (RP) with European Qualified Person eligibility. The role requires managing the QMS, ensuring GMP compliance, and supporting regulatory submissions and inspections in a hybrid Dublin setting.

The successful candidate will lead QA activities, coordinate CAPAs, oversee supplier and product compliance, and partner with HPRA to maintain regulatory readiness. Available travel may be required.