Quality Assurance Specialist (QP)

Bausch + Lomb Corporation, (NYSE/TSX: BLCO), is solely 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.

The company is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses, and other eye surgery products. 

Our highest priority is the well-being of the people we serve. By listening to our customers and patients, by constantly honing our innovation edge, by executing with integrity and excellence, we strive to earn the trust of our partners and stakeholders.

Over the last 167 years, Bausch + Lomb has become a global hallmark for innovation and quality.  Our talented and motivated colleagues work relentlessly to invent new materials, engineer new technologies, and ultimately bring new innovations to help people see better to live better.

The Quality Assurance Specialist/RP at Bausch + Lomb Ireland Limited has responsibility for the management and maintenance of Global External Quality Management Systems (QMS) and the BLIL Quality Management System.

KEY RESPONSIBILITIES:

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 authorisations (WDA, MIA, ASR)
• Ensure processes are maintained in support of BLIL as MAH
• Manage 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
• Review and approve Non-Conformances (NC), CAPA, change controls and complaints.
• Perform QP disposition, ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the Member State where certification takes place, in accordance with the Externally Manufactured Products.
• Develop, maintain and approve Quality Agreements in order to ensure that these are current, retrievable and meet the global Bausch + Lomb Quality standards for Quality Agreements.
• Perform Periodic review of QMS and operational procedures for regulatory compliance through an internal audit system.
• Support periodic Management Review meetings.
• Initiate change controls as required.
• Support preparation of and deliver annual GMP and GDP training.
• Communicate with Global B+L colleagues in an effective and timely manner.
• Abide by data integrity requirements at all times.

The key responsibilities assigned to the Quality Assurance Specialist at Bausch + Lomb Ireland Limited relate to the management, development and administration of the Global Quality Management System (QMS) and BLIL QMS operational procedures.

Desirable to have QP qualification - 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.

Responsibilities include but are not limited to:

• Preparation, implementation and ongoing maintenance of the QMS systems and operational procedures, policies and other related documentation, in compliance with applicable legislation, regulations and regulatory guidance.
• Management of third parties (External Manufacturing Organizations (EMOs) and affiliates) including regular review and auditing of their Quality Management Systems either by BLIL personnel or through the management of audits contracted to qualified third parties, to ensure compliance with applicable legislation and regulations.
• Annual review of supplier and customer bona fides to verify compliance with Guidelines on Good Distribution Practice.
• Batch record review to verify compliance with GMP and Market Authorisation prior to batch release.
• Review, and where appropriate, preparation and regular update of technical agreements with licensees and 3rd party contractors.
• Regular presentation and review of intercompany Quality service provider performance against measures relating to the BLIL Quality Objectives at periodically held Quality Operations meetings.
• Periodic review of QMS and operational procedures for regulatory compliance through internal audit system.
• Scheduling periodic Quality Operations management review meetings with third parties, annual Quality Management Review meetings, and 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.
• Raising of change controls as required.
• Provide support for all MIA/MAH/WDA activities as required.
• Escalation of issues to EMEA Quality Director as appropriate.

PERSON SPECIFICATION

• 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 work on their own initiative and within teams.
• Be able to analyse complex problems and identify solutions.
• Strong communication and organizational skills.
• Excellent ability to deliver results, with strong interpersonal and influencing skills.
• Ability to build relationships internally and externally.
• Trained auditor.
• Available to travel if required to fulfil role.

The masculine is used in this publication without prejudice for the sake of conciseness.
Bausch & Lomb is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates.

We are an equal opportunity employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply. Accommodations for job applicants with disabilities are available on reques.

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