Quality Systems Specialist

Viatris; Dublin; On-site; EUR 65,000 - 80,000; Full time

Benefits offered by this job

Competitive salaries

Inclusive environment

Job summary

Viatris Ireland is hiring a Quality Systems Specialist to design and implement site Quality Systems for combination products, including SOPs, CAPA, investigations and internal audits. You will collaborate with Engineering, Validation, Manufacturing and Regulatory teams to maintain inspection readiness, support regulatory reviews and drive continuous improvement.

Degree plus 3+ years' experience, and proficiency with TrackWise, SAP and MS Office are required.

Qualifications

• Degree-level education with 3+ years industry experience.
• Experience designing and implementing quality systems.
• Knowledge of EU & US regulatory requirements.
• Proficiency with TrackWise, SAP and MS Office.
• Ability to work flexibly in a changing environment; strong attention to detail.

Responsibilities

• Develop and implement site Quality Systems for combination products (SOPs, document control, change control, investigations, CAPA, internal auditing, vendor qualification).
• Provide QA support to ensure inspection readiness.
• Collaborate with Engineering, Validation, Manufacturing, Regulatory and Global Quality.
• Support operation of the site Training system and prepare relevant training material.
• Regulatory compliance; support Dublin Respiratory reviews and generation of supporting documents.
• Keep abreast of regulatory initiatives and new guidance/requirements.
• Drive continuous improvement in product and process quality; ensure EH&S compliance.
• Support and execute other duties as assigned.

Skills

Quality systems

Regulatory knowledge

Documentation

Attention to detail

Communication

Team collaboration

Adaptability

Education

Bachelor's degree (or higher)

Tools

TrackWise

SAP

MS Office

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. Every day, we rise to the challenge to make a difference and here's how the Quality Systems Specialist role will make an impact:

Key responsibilities for this role include:

• Develop and implement site Quality Systems to support the manufacture and release of Combination products, including SOPs, document control, change control, investigations, CAPA, internal auditing, Vendor qualification & management, material and batch disposition, complaints and annual product review.


• Provide QA support to site to ensure Inspection Readiness.


• Collaborate with key stakeholders including Engineering, Validation, Manufacturing, Regulatory and Global Quality.


• Support operation of the site Training system, including preparing and presenting relevant training material, as required.


• Regulatory Compliance; support Dublin Respiratory reviews and generation of supporting documents including API Declaration, Approved Product List, Approved Oversight List.


• Keep abreast of regulatory initiatives and new guidance/requirements.


• Ensure compliance with appropriate regulatory guidance documents, while driving improvements in product and process quality.


• Support the implementation of the Continuous Improvement program by identifying, leading and implementing improvements.


• Comply with company and Legislative Environment, Health and Safety Requirements.


• Support and execute any other duties as assigned.

Support and execute any other duties as assigned.

Support and execute any other duties as assigned.

The minimum qualifications for this role are:

• Educated to degree level with 3+ years industry experience.


• Working knowledge of EU & US regulatory requirements.


• Experience in designing and implementing quality systems and/or a start-up an advantage.


• Experience in or knowledge of inhalation dosage forms an advantage.


• High proficiency in Microsoft Word/Excel/PowerPoint/MS Project etc.


• Proficiency in electronic systems/databases such as documentation, Trackwise, SAP etc.


• Good team working and strong communication skills across functions and organization.


• An ability to work flexibly in a changing environment.


• Good attention to detail and priority management essential.


• Flexibility to learn new skills and take on new tasks and responsibilities.


• The ability to work under pressure to demanding schedules is important, as is the ability to work on one's own initiative.

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.

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.

Viatris is an Equal Opportunity Employer.

Viatris is a global healthcare company whose mission is to empower people worldwide to live healthier at every stage of life. We meet the needs of patients around the world by acting decisively with ingenuity and resolve. Whether we're developing new medicines, working to maintain a resilient supply of needed therapies, or pursuing bold innovation, we strive to deliver solutions that are effective at scale and built to endure. We're purpose-built to make an impact with a broad portfolio that spans generics, value-added medicines, established brands, and innovative medicines that address areas of significant unmet need. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai, and Hyderabad, India.