Quality System Specialist

Viatris; The Borough District of Drogheda; On-site; EUR 55,000 - 75,000; Full time

Job summary

McDermott Laboratories Limited, part of Viatris, seeks a Quality Assurance professional to oversee GxP documentation, deviations, CAPAs and change controls within a GMP/GDP environment. You will manage TrackWise records, supplier qualification, and QA governance across the EU network.

Ideal candidates hold a science/pharma degree and have solid experience in quality systems, documentation review, and CAPA processes, with a proactive, cross-functional approach to compliance and inspections.

Qualifications

• Degree in a scientific, pharmaceutical or related discipline.
• Experience in QA, quality systems or quality compliance in the pharmaceutical industry.
• Strong knowledge of GMP, GDP and QMS.
• Experience managing deviations, investigations and CAPAs.
• Experience coordinating Change Controls to closure.
• Experience reviewing GxP documentation with third-party sites.
• Experience with supplier/vendor qualification and performance oversight.

Responsibilities

• Review third party GxP documentation to support batch disposition of respiratory products.
• Manage and review product complaints.
• Develop and coordinate the change control system per SOPs and ensure follow-up and closure of open items.
• Manage PMSI and deviation systems, including TrackWise records, assisting investigations to determine root causes and CAPAs implemented.
• Ensure Quality Technical Agreements (QTAs) are in place with affiliate and third party suppliers/service providers.
• Manage product returns as per GDP guidelines.
• Coordinate approval of new vendors and customers per GDP guidelines.
• Carry out Bona Fide checks on suppliers and customers annually.
• Maintain and coordinate MAH systems (Product Lists, QTAs, PQRs).
• Support self-inspection system and development/implementation of QMS at Mylan Regional EU.
• Provide weekly/monthly KPIs for relevant systems.

Skills

Quality Assurance

Change Control

CAPA Management

Root Cause Analysis

GxP Documentation Review

Education

Bachelor's degree in science/pharma

Tools

TrackWise

Job description

McDermott Laboratories Limited

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

We have been included on number of award lists that demonstrate the impact we are making.

Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.

For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.

The Role & What You Will Be Doing

• Review of third party GxP documentation to support batch disposition of respiratory products.
• Management and review of product complaints
• To manage and develop the change control system in accordance with the relevant SOPs and to coordinate the follow up and closure of all open items.
• To manage the Pre-Market Supply Incident (PMSI) and deviation systems, including, but not limited to, the raising of PMSI/deviation records in the Trackwise system, assisting in investigations to determine root causes and the review of third-party investigation reports to ensure that root causes are determined and CAPAs (where applicable) have been implemented.
• To ensure Quality Technical Agreements (QTAs) are in place with affiliate and third party suppliers/service providers as appropriate.
• To manage product returns as per current GDP guidelines.
• To manage and coordinate the approval of new vendors and customers as per GDP guidelines.
• To carry out annual Bona Fide checks on suppliers and customers as per GDP guidelines.
• Carry out annual reviews/assessments on vendors and service providers to ensure appropriate performance of third party suppliers/service providers.
• To maintain and coordinate the MAH systems (e.g. Product Lists, QTAs, PQRs).
• To carry out annual reviews of manufacturing/packaging/release PQRs as part of the company's responsibilities as QP release site and Marketing Authorisation Holder.
• To maintain and update the department's training and Learning Management systems.
• Coordinate the distribution of wholesale related SOPs to relevant non-QA staff through the Learning Management System.
• The administration and conducting of risk assessments.
• To maintain and develop the SOP system in relation to the update, logging and distribution of SOPs.
• To support the self-inspection system.
• Actively support the development and implementation of the Quality Management System at Mylan Regional EU.
• Provide weekly and/or monthly KPIs for relevant systems to management.
• Compliance with current Good Manufacturing Practices (GMP), Good Distribution Practices (GDP) and Standard Operating Procedures (SOPs) to ensure an audit ready facility.
• To adhere to all company and legislative health, safety and environmental requirements.
• Any other duties as assigned by the Quality Systems Manager/Quality Director.

About Your Skills & Experience

• Degree in a scientific, pharmaceutical or related discipline.
• Experience working in a Quality Assurance, Quality Systems or Quality Compliance role within the pharmaceutical industry.
• Strong knowledge and practical experience of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and Quality Management Systems (QMS).
• Experience managing deviations, investigations, root cause analysis and CAPAs.
• Experience managing and coordinating Change Controls through to timely closure.
• Experience reviewing GxP documentation and working with third-party manufacturing sites, suppliers or service providers.
• Experience using an electronic Quality Management System, ideally TrackWise.
• Experience with supplier/vendor qualification, quality oversight and performance management.

Benefits at Viatris

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Some of our benefits include the following on top of a competitive