Quality Systems Specialist

Viatris; Sutton; On-site; EUR 50,000 - 68,000; Full time

Job summary

Viatris is seeking a Quality Systems Specialist to join McDermott Laboratories Limited. The role focuses on designing and implementing site Quality Systems to support the manufacture and release of combination products, ensuring regulatory compliance and robust CAPA processes.

You will collaborate with Engineering, Validation, Manufacturing and Regulatory teams, maintain document control, manage audits, and support training and continuous improvement initiatives across the site in Ireland.

Qualifications

• 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.

Responsibilities

• Develop and implement site Quality Systems to support 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 Engineering, Validation, Manufacturing, Regulatory and Global Quality to drive quality improvements.

Skills

Quality systems

Regulatory knowledge

Documentation control

Communication skills

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.