EU QP QA Specialist - GMP, QMS, Inspections (Hybrid Dublin)

Bausch + Lomb; Dublin; Hybride; EUR 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Hybrid work model

Equal opportunity employer

Résumé du poste

Bausch + Lomb Ireland Limited seeks a Quality Assurance Qualified Person to manage the QMS, ensure GMP compliance, and support HPRA inspections. Hybrid role with three days onsite at City West, Dublin.

Responsibilities include maintaining the QMS, supporting MAH status, approving batch releases, and coordinating CAPAs and HPRA interactions. The role demands strong QA expertise and regulatory knowledge in eye health products.

Qualifications

• BSc (Hons) in Science or equivalent.
• QP qualification.
• 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.
• Good communication skills
• The ability to motivate and influence people
• Self-starter, highly motivated with the ability to prioritize
• Ability to work on own initiative; high attention to detail
• Good team member with excellent interpersonal and influencing skills.

Responsabilités

• Manage the QMS, ensure the QMS is fit for purpose, approving 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 communications with HPRA and represent BLIL.
• Provide QA expertise and manage Quality issues to closure.
• Support HPRA inspections and prepare responses.
• Support internal compliance audits of BLIL operations.
• Prepare and approve HPRA variations.

Connaissances

Communication skills

Leadership

Self-motivation

Initiative

Attention to detail

Teamwork

Formation

BSc (Hons) in Science

Description du poste

Bausch + Lomb Ireland Limited seeks a Quality Assurance Qualified Person to manage the QMS, ensure GMP compliance, and support HPRA inspections. Hybrid role with three days onsite at City West, Dublin.

Responsibilities include maintaining the QMS, supporting MAH status, approving batch releases, and coordinating CAPAs and HPRA interactions. The role demands strong QA expertise and regulatory knowledge in eye health products.