Senior Quality Assurance Specialist

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Date: Nov 6, 2024

Location: IE - Dublin, Ireland - All, IE

Company: Bausch Health

 

Bausch Health Companies, is one of the leading pharmaceutical companies, that has been marketing its own and third-party products for many years now, while nurturing strong customer-oriented and consumer-centric approach in its everyday business. As a result, we are very proud of our strong reputation among healthcare professionals and consumers. Our goal is to make this leading position even stronger for years to come.

In our BIRL Quality Assurance team, we are looking for:

Senior Quality Assurance Specialist

  Location: Bausch Health Ireland Limited (BIRL)

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.

 

· Quality responsible for leading and/or approval of deviations, CAPA, change controls, complaints and recalls as they relate to Marketing Authorisation Holder and GMP responsibilities of BIRL
· Management of third parties (External Manufacturing Organisations (EMOs) and affiliates) including regular review and auditing of their Quality Management Systems either by BIRL personnel or through the management of audits contracted to qualified third parties, to ensure compliance with applicable legislation and regulations.
· 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 BIRL Quality Objectives at periodically held Quality Operations meetings.
· Prepare and present updates on Quality Operations management during 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 BIRL Quality and Regulatory Compliance Policy and Objectives for continuing suitability.
· Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.  Periodic review of QMS and operational procedures for regulatory compliance through internal audit system.
· 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 MIA/MAH activities as required.
· Escalation of 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 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.

· Available to travel if required to fulfil role.

 

 

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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.