Qualified Person

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

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.

Viatris is an Equal Opportunity Employer.