Quality Assurance Specialist for Device Development

3 days ago


Dublin, Dublin City, Ireland Viatris Inc. Full time

Viatris Inc. is a global healthcare company that helps people live healthier at every stage of life.

We are committed to building a truly diverse, inclusive and authentic workplace where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

The Senior Quality Assurance Specialist, Device Development Assurance role will be responsible for providing quality oversight of equipment installation and qualification, computer system validation, preventative maintenance and calibration schedules to ensure compliance with regulatory requirements.

This includes providing quality oversight of documentation relating to equipment use and qualification to ensure compliance with regulatory standards, ensuring all data integrity requirements are met for all laboratory equipment and systems, and maintaining daily engagement with the laboratory team to ensure resolution and proper follow-up.

In addition, this role will provide quality oversight of material controls – receipt, inspection, storage and traceability, test method validation, stability product management, and general development and improvement of the GDD Quality System through management of CAPA, internal audit program, documentation, complaints, trending and training.

Supporting third-party inspections/audits and quality oversight of development laboratory activities are also key responsibilities of this role.

To be successful in this role, you will need to have a bachelor's degree in science, engineering or biotechnology, minimum 3-5 years relevant professional experience in GMP/Medical Device Industry quality operations, and demonstrated understanding of GMP, ISO13485, CFR 820, MDD 93/42/EEC & MDR 2017/745.

Strong problem-solving and analytical skills, knowledge of core manufacturing/laboratory operation principles, excellent communication skills, and ability to work independently and with minimal direction are also essential for this role.



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