Quality Assurance Specialist, Responsible Person (RP)

Worklane GmbH; Dublin; Hybrid; EUR 95,000 - 130,000; Full time

Job summary

Bausch + Lomb Ireland Limited is seeking a Quality Assurance professional to act as European Qualified Person with responsibility for managing the QMS, ensuring GMP compliance, and supporting BLIL authorisations and HPRA interactions. Hybrid role with three onsite days in City West, Dublin.

Key requirements include a BSc in science, a QP qualification, and at least five years in QA within healthcare. Strong communication, initiative, and attention to detail are essential to drive continuous

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 Excellent ability to deliver results, with strong interpersonal and influencing skills.

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.
• Ensures that each finished medicinal product batch has been manufactured in accordance with GMP and the MA.
• Review, and where appropriate, preparation and regular update of technical agreements with licensees and 3rd party contractors.
• Periodic review of QMS and operational procedures for regulatory compliance through internal audit system.
• Participating in periodic Quality Operations management review meetings with third parties, annual Quality Management Review meetings, and participating in preparing the agenda and minutes for both meetings.
• Attending the annual Quality Management Review meeting and participating in the review of the BLIL Quality and Regulatory Compliance Policy and Objectives for continuing suitability.
• Implementation of the Self Inspection/Internal Quality Audit program.
• Overall responsibility for reporting and investigation of non-conformances and identification of CAPAs to ensure continuous improvement of the QMS and operational procedures.
• Escalation of issues as appropriate.
• The QP must be eligible to act as a European Qualified Person (QP), certifying products in compliance with 2001/83/EC, 2003/94/EC and Annex 16.

Skills

Communication

Motivation & influence

Self-starter

Initiative

Attention to detail

Interpersonal skills

Education

BSc (Hons) in Science or equivalent

QP qualification

Job description

Location: IE - Dublin, IE

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.

Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries , extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.

The Quality Assurance, QP at Bausch + Lomb Ireland Limited has responsibility for the management and maintenance of BLIL Quality Management System. Furthermore, the job holder is acting as qualified person as per EU GMP.

Please note: This is a hybrid role woth 3 days onsite required in City West, Dublin.

Responsibilities include but are not limited to:

• 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.
• Ensures that each finished medicinal product batch has been manufactured in accordance with GMP and the MA.
• Review, and where appropriate, preparation and regular update of technical agreements with licensees and 3rd party contractors.
• Periodic review of QMS and operational procedures for regulatory compliance through internal audit system.
• Participating in periodic Quality Operations management review meetings with third parties, annual Quality Management Review meetings, and participating in preparing the agenda and minutes for both meetings.
• Attending the annual Quality Management Review meeting and participating in the review of the BLIL Quality and Regulatory Compliance Policy and Objectives for continuing suitability.
• Implementation of the Self Inspection/Internal Quality Audit program.
• Overall responsibility for reporting and investigation of non-conformances and identification of CAPAs to ensure continuous improvement of the QMS and operational procedures.
• Escalation of issues as appropriate.
• The QP must be eligible to act as a European Qualified Person (QP), certifying products in compliance with 2001/83/EC, 2003/94/EC and Annex 16.

Qualifications/ Education:

• 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 Excellent ability to deliver results, with strong interpersonal and influencing skills.

Available to travel if required to fulfil role.

Bausch & Lomb is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates.