Qualified Person (12 months fixed term contract)

Viatris Inc.; Dublin; On-site; EUR 50,000 - 75,000; Full time

Job summary

A leading global healthcare company is seeking a Qualified Person in Dublin on a 12-month fixed-term contract. The role involves certifying medicinal products, coordinating quality assurance operations, and ensuring compliance with regulatory requirements. Ideal candidates will have experience in the pharmaceutical industry, strong communication skills, and attention to detail. This position offers a collaborative culture, competitive salary, and opportunities for career progression in an inclusive environment.

Benefits

Competitive salary

Inclusive environment

Career progression opportunities

Work-life balance initiatives

Qualifications

• Meets qualification requirements for a QP as listed in EU Directive 2001/83/EC.
• Previous experience of certifying medicinal product is an advantage.
• Proven quality experience in pharmaceutical industry encompassing analytical, manufacturing or packaging operations.

Responsibilities

• Certify medicinal products according to EU regulations.
• Assist in QA operational duties relating to product disposition.
• Ensure compliance with product release procedures.

Skills

Certifying medicinal products

Quality Assurance in pharmaceuticals

Teamwork

Attention to detail

Communication skills

Education

Qualifications for a QP as per EU Directive 2001/83/EC

Tools

Trackwise

SAP

MES

Job description

**Cookie Notice**Qualified Person (12 months fixed term contract) page is loaded## Qualified Person (12 months fixed term contract)locations: Baldoyle, Dublin, Irelandtime type: Full timeposted on: Posted Todayjob requisition id: R5665461McDermott Laboratories LimitedAt VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access – Providing high quality trusted medicines regardless of geography or circumstance; Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and Partnership – Leveraging our collective expertise to connect people to products and services. 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**Every day, we rise to the challenge to make a difference and here’s how the **Qualified Person** role will make an impact:* Certify medicinal product in accordance with requirements of product marketing authorization, EU Directive 2001/83/EC & 2001/20/EC and EU GMP Annex 16.* Assist in the coordination of the QA operational duties relating to product disposition.* Participate in investigations and risk assessments related to manufacturing deviations and changes and ensuring appropriate actions are implemented.* Ensure product release procedures comply with current regulatory and company requirements.* Ensure product periodic quality reviews are performed in timely manner and are reviewed and appropriate actions implemented.* Approve declaration of GMP for API’s.* Ensure continued effectiveness of site Quality System through regular self-inspections and spot checks.* Provide guidance and leadership to the Quality Assurance team.* Review of results from on-going stability studies and ensure appropriate actions are implemented.* Review equipment qualification and process validation and cleaning validation protocols and reports* Perform technical assessments of contract manufacturing facilities and equipment vendors.* Review of Analytical test methods as per regulatory filings, verification and validation of test methods* Review and approve of MBR’s as per Regulatory dossiers.**About Your Skills & Experience**For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:* Meets qualification requirements for a QP as listed in EU Directive 2001/83/EC.* Previous experience of certifying medicinal product (previously or currently listed as a QP on an EU manufacturing licence) would be an advantage.* Proven quality experience in pharmaceutical industry encompassing analytical, manufacturing or packaging operations.* Working knowledge of EU and US GMPs.* Proficiency in electronic systems/databases such as documentation, Trackwise, SAP, MES etc.* Experience with combination products and product development/introduction would be an advantage.* 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.At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.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. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.**Diversity & Inclusion at Viatris**At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit**Sustainability at Viatris**Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visitAt 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.