Senior Quality Assurance Specialist

Career Opportunities: Senior Quality Assurance Specialist (12946)Requisition ID 12946 - Posted - Management - Quality - IE - Dublin - City (1)
Bausch Health Companies is one of the leading pharmaceutical companies, marketing its own and third-party products for many years while nurturing a strong customer-oriented and consumer-centric approach in its everyday business. As a result, we are proud of our strong reputation among healthcare professionals and consumers. Our goal is to strengthen this leading position for years to come.
In our BIRL Quality Assurance team, we are looking for:
Senior Quality Assurance Specialist The key responsibilities assigned to the Senior Quality Assurance Specialist at Bausch Health Ireland Limited relate to the management, development, and administration of the Global Quality Management System (QMS), BIRL QMS operational procedures, and Marketing Authorisation Holder responsibilities.
Lead and/or approve deviations, CAPA, change controls, complaints, and recalls related to Marketing Authorisation Holder and GMP responsibilities of BIRL.Manage third parties (External Manufacturing Organisations (EMOs) and affiliates) including regular review and auditing of their Quality Management Systems to ensure compliance with applicable legislation and regulations.Review, and where appropriate, prepare and regularly update technical agreements with licensees and 3rd party contractors.Present and review intercompany Quality service provider performance against measures relating to the BIRL Quality Objectives at Quality Operations meetings.Prepare and present updates on Quality Operations management during review meetings, including preparing the agenda and minutes.Attend the annual Quality Management Review meeting and participate in the review of the BIRL Quality and Regulatory Compliance Policy and Objectives.Ensure that self-inspections are performed at appropriate intervals and necessary corrective measures are implemented.Overall responsibility for reporting and investigating non-conformances and identification of CAPAs to ensure continuous improvement of the QMS.Raise change controls as required.Provide support for MIA/MAH activities as required.Escalate issues to Quality management as appropriate.The minimum requirements: BSc (Hons) in Science or equivalent.Thorough working knowledge of GMPs and regulatory expectations for medicinal products and medical devices.Minimum of 5 years of experience working in Quality Assurance in the pharmaceutical industry.Trained auditor.Ability to work independently and within teams.Ability to analyze 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.Available to travel if required to fulfill the role.The masculine is used in this publication without prejudice for the sake of conciseness. Bausch Health is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates. Bausch Health is an EEO/AA employer M/F/D/V.

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