Senior Qualified Person | GMP Compliance & QA Leadership

Viatris; Sutton; On-site; EUR 85,000 - 120,000; Full time

Benefits offered by this job

Competitive salary

Inclusive environment

Career development

Job summary

McDermott Laboratories Limited, part of Viatris, seeks a Qualified Person to certify medicinal products under EU directives. The role leads QA activities ensuring compliant product disposition, release and GMP compliance across manufacturing, packaging and analytics.

The position requires EU QP qualification, 5+ years in pharma QA, and proficiency with Trackwise, SAP and MES. Based in Ireland, Leinster, you will work in a fast-paced, evolving environment with excellent salary and benefits.

Qualifications

• Meets qualification requirements for a QP as listed in EU Directive 2001/83/EC.
• Previous experience certifying medicinal products would be an advantage.
• 5+ years quality experience in pharmaceutical industry (analytical, manufacturing or packaging).
• Working knowledge of EU and US GMPs.
• Proficiency in electronic systems/databases such as documentation, Trackwise, SAP, MES.
• Experience with combination products and product development/introduction would be an advantage.
• Good team working and strong communication across functions.
• Ability to work flexibly in a changing environment.
• Attention to detail and priority management are essential.
• Willingness to learn new skills and take on new tasks.

Responsibilities

• Certify medicinal product in accordance with MAO, EU directives and GMP Annex 16.
• Coordinate QA operational duties related to product disposition.
• Participate in investigations and risk assessments for deviations and changes.
• Ensure product release procedures comply with regulatory and company requirements.
• Ensure timely performance of product periodic quality reviews and implement actions.
• Review and approve MBRs as per regulatory dossiers.
• Provide guidance and leadership to the QA team.
• Review stability, equipment qualification and process validation protocols.
• Perform technical assessments of CM facilities and vendors.
• Review analytical test methods per regulatory filings and validation.

Skills

Quality mindset

Strong communication

Team collaboration

Attention to detail

Flexibility

Education

QP certification (EU)

Tools

Trackwise

SAP

MES

Job description

McDermott Laboratories Limited, part of Viatris, seeks a Qualified Person to certify medicinal products under EU directives. The role leads QA activities ensuring compliant product disposition, release and GMP compliance across manufacturing, packaging and analytics.

The position requires EU QP qualification, 5+ years in pharma QA, and proficiency with Trackwise, SAP and MES. Based in Ireland, Leinster, you will work in a fast-paced, evolving environment with excellent salary and benefits.