Hybrid QA Specialist & EU GMP QP (Dublin)

Bausch + Lomb; Dublin; Hybrid; EUR 110,000 - 150,000; Full time

Job summary

Bausch + Lomb Ireland Limited is seeking a Quality Assurance Qualified Person to manage the QMS and ensure GMP compliance for medicinal products and medical devices. Hybrid role with three onsite days in City West, Dublin.

The successful candidate will oversee HPRA interactions, CAPA processes, and regulatory variations while guiding BLIL through audits and inspections. A BSc in science and a QP qualification are required, with 5+ years QA experience.

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 and high attention to detail.

Responsibilities

• Manage the QMS, ensure the QMS is fit for purpose, making changes as necessary 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 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.
• Ensure annual review of supplier and customer bona fides to verify compliance with Guidelines on Good Distribution Practice.
• Ensure Batch record review to verify compliance with GMP and Market Authorization prior to batch release.
• To approve or reject finished products.

Skills

QP qualification

Attention to detail

Communication skills

Education

BSc (Hons) in Science or equivalent

Job description

Bausch + Lomb Ireland Limited is seeking a Quality Assurance Qualified Person to manage the QMS and ensure GMP compliance for medicinal products and medical devices. Hybrid role with three onsite days in City West, Dublin.

The successful candidate will oversee HPRA interactions, CAPA processes, and regulatory variations while guiding BLIL through audits and inspections. A BSc in science and a QP qualification are required, with 5+ years QA experience.