Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it—where your skills and values drive our collective progress and impact.
The Quality Assurance Specialist at Bausch Health Ireland Limited will have responsibility for the management and maintenance of BIRL Quality Management Systems and Global External Manufacturing Quality Systems (QMS) and Marketing Authorisation Holder responsibilities.
Key responsibilities include, but are not limited to:
- Quality responsible person for deviations, CAPA, change controls, complaints and recalls as they relate to MAH, GDP and GMP responsibilites of BIRL
- Conduct responsibilities as a deputy responsible person under GDP regulations
- Support the management of third parties (External Manufacturing Organisations (EMOs) and affiliates) including review of Quality agreements and licences as applicable. Reviewing, and where appropriate, preparation and regular update of technical agreements with supplier, customer and 3rd party contractors.
- 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.
- Participating in self-inspections and implementing necessary corrective measures.
- Provide support for all MIA/MAH activities as required.
- Escalation of issues to Quality management as appropriate.
The minimum requirements:
- BSc (Hons) in science or equivalent.
- Experience working as Responsible Person / Deputy Responsible Person
- Minimum of 5 years of experience working in Quality Assurance in the pharmaceutical 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.
- Thorough working knowledge of GDPs and GMPs and experience in a GDP and GMP environments
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We are an Equal Opportunity Employer. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.