Bausch Health Companies is one of the leading pharmaceutical companies, marketing its own and third-party products while nurturing a strong customer-oriented and consumer-centric approach. We take pride in our strong reputation among healthcare professionals and consumers, and our goal is to strengthen this position 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 include the management, development, and administration of the Global Quality Management System (QMS), BIRL QMS operational procedures, and Marketing Authorisation Holder responsibilities:
1. Lead and/or approve deviations, CAPA, change controls, complaints, and recalls related to Marketing Authorisation Holder and GMP responsibilities of BIRL.
2. 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.
3. Review, prepare, and regularly update technical agreements with licensees and third-party contractors.
4. Present and review intercompany Quality service provider performance against measures relating to the BIRL Quality Objectives at periodically held Quality Operations meetings.
5. Prepare and present updates on Quality Operations management during review meetings, and prepare the agenda and minutes for both meetings.
6. Attend the annual Quality Management Review meeting and participate in the review of the BIRL Quality and Regulatory Compliance Policy and Objectives for continuing suitability.
7. Ensure that self-inspections are performed at appropriate intervals and necessary corrective measures are implemented. Periodically review QMS and operational procedures for regulatory compliance through the internal audit system.
8. Report and investigate non-conformances and identify CAPAs to ensure continuous improvement of the QMS and operational procedures.
9. Raise change controls as required and provide support for MIA/MAH activities.
10. Escalate issues to Quality management as appropriate.
The minimum requirements:
1. BSc (Hons) in Science or equivalent.
2. Thorough working knowledge of GMPs and regulatory expectations for medicinal products and medical devices.
3. Minimum of 5 years of experience working in Quality Assurance in the pharmaceutical industry.
4. Trained auditor.
5. Ability to work on initiative and within teams.
6. Ability to analyze complex problems and identify solutions.
7. Strong communication and organizational skills.
8. Excellent ability to deliver results, with strong interpersonal and influencing skills.
9. Ability to build relationships internally and externally.
10. Available to travel if required to fulfill 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.
Job Types: Full-time, Permanent
Additional pay:
* Performance bonus
Benefits:
* Bike to work scheme
* Company events
* Employee assistance program
* Flexitime
* Gym membership
* On-site parking
* Private medical insurance
* Wellness program
* Work from home
Schedule:
* Monday to Friday
Work Location: Hybrid remote in Citywest, CO. Dublin
Reference ID: 12946
#J-18808-Ljbffr