Device Development Assurance Specialist
The Device Development Assurance Specialist shall support the general maintenance and improvement of the Device Development Assurance Specialist, with a particular focus on quality oversight of and support to the operation of the GDD development laboratories.
Every day, we rise to the challenge to make a difference and here’s how the Device Development Assurance Specialist role will make an impact:
* Provide Quality oversight of development laboratory activities against local GDD procedures, Global Viatris Policies, and product specific requirements, including but not limited to:
* Test Equipment Management – Qualification, Calibration, Preventative Maintenance, Traceability
* Material controls – Receipt, Inspection, Storage and Traceability
* Test Method Validation
* Stability product management oversight
* Continuous Improvement – Procedures, Work Instructions, CAPA, Investigations
* Support the general development and improvement of the GDD Quality System through management of CAPA, Internal Audit program, documentation, complaints, trending and training
* Support third-party inspections/audits
* Quality oversight of development laboratory activities
* Support CAPA, Internal Audit program, documentation, complaints, trending and training
* Support third-party inspections/audits
About Your Skills & Experience
* Bachelor’s degree in Science, Engineering or Biotechnology
* Minimum 3-5 years relevant professional experience (GMP / Medical Device Industry quality operations)
* Demonstrated understanding of GMP, ISO13485, CFR 820, MDD 93/42/EEC & MDR 2017/745
* Strong problem solving and analytical skills
* Possess knowledge of core manufacturing / laboratory operation principles
* Excellent communicator; clear and concise in communications with External and Internal partners with the ability to work flexibly across a multi-disciplinary team in jointly achieving departmental goals & established timelines
* A team player willing to support any other organisational needs/activities outside primary expertise to continuously develop the business
* Demonstrated ability to perform in a high-performing workforce
* Ability to work independently and with minimal direction
* Ability to define, organize, and manage individual and team tasks
* Proficient in MS office applications
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.
Benefits at Viatris
* Excellent career progression opportunities
* Work-life balance initiatives
* Bonus scheme
* Health insurance
* Pension
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 Diversity and Inclusion at Viatris
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 visit Corporate Responsibility at Viatris
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.
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