Qualified Person

Viatris; Dublin; On-site; EUR 120,000 - 150,000; Full time

Job summary

Viatris is seeking a Qualified Person (QP) to certify medicinal products in line with EU Directive 2001/83/EC and EU GMP Annex 16. The role requires leading QA activities to ensure compliant product disposition and release.

The successful candidate will coordinate investigations, risk assessments, and periodic quality reviews, while reviewing equipment qualification and analytical methods. Strong cross-functional collaboration and knowledge of EU/US GMPs are essential.

Qualifications

• Meets qualification requirements for a QP per EU Directive 2001/83/EC.
• 5+ years quality experience in pharmaceutical industry encompassing analytical, manufacturing or packaging operations.
• Working knowledge of EU and US GMPs.
• Proficiency with electronic systems/databases such as documentation, TrackWise, SAP, MES.
• Experience with combination products and product development would be an advantage.
• Good team working and strong communication across functions and organization.

Responsibilities

• Certify medicinal product in accordance with MA requirements, EU Directive 2001/83/EC & 2001/20/EC and EU GMP Annex 16.
• Assist in coordinating 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 with appropriate actions implemented.
• Approve declaration of GMP for APIs.
• Provide guidance and leadership to the QA team.
• Review results from ongoing stability studies and ensure appropriate actions are implemented.
• Review equipment qualification and process validation and cleaning validation protocols and reports.

Skills

Teamwork and communication

Attention to detail

Adaptability

Prioritization

GMP knowledge

Education

QP qualification per EU Directive 2001/83/EC

Tools

TrackWise

SAP

MES

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 Qualified Person role will make an impact:

Key responsibilities for this role include:

• 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.

The minimum qualifications for this role are:

• 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.
• 5 years plus 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 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.

Viatis is an Equal Opportunity Employer.

Viatis 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.