Senior Qualified Person – Pharma QA & Compliance

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

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.