QA Executive Level III

Mylan (Galway, Ireland) 3 days ago

Primary Location: IRE-Connacht-Galway

Organization: Mylan Teoranta

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via:

  • Access – Providing high quality trusted medicines regardless of geography or circumstance;

  • Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and

  • Partnership – Leveraging our collective expertise to connect people to products and services.

Every day, we rise to the challenge to make a difference and here’s how the QA Executive Level III role will make an impact:

Key responsibilities for this role include:

  • Lead specific Quality management system elements such as GMP investigations, Change Control, CAPA and Risk Assessment and Customer Quality Complaints/Medical Device Vigilance systems.

  • Support the Qualified Person(s) to lead and perform data review audits (Batch Production Records, Validation Documents and Development Documentation, Quality Control Data as required).

  • Support the Quality Manager in the definition and maintenance of the annual internal and external audit programs, annual product reviews and quality management reviews for Viatris.

  • Support the quality organisation to meet the needs of the growing business; using technical expertise, skills knowledge and experience as required to resolve problems and share knowledge.

  • Review and approve suppliers / service providers, including the support of audits of critical suppliers where required.

  • Support the Quality Manager with hosting external audits and regulatory inspections.

  • May act as Principal Project Quality Lead for new and existing Viatris projects providing advice and guidance to operational teams with support and guidance from the Quality Manager.

  • Create, maintain and deliver training in quality-related topics to Viatris personnel.

  • Support the Quality Assurance team in preparation of monthly/quarterly/annual reports to be submitted to senior management and Viatris departments to ensure visibility of QMS requirements and performance, including the compilation of quality metrics to facilitate the monitoring and management of the Viatris Quality System.

The minimum qualifications for this role are:

  • Minimum of a Bachelor’s Degree in a Science- or Engineering-related discipline.

  • Minimum of 3 years’ experience within a Quality Assurance role; however, a combination of experience and/or education will be taken into consideration.

  • Experience with TrackWise or similar electronic document management systems is highly desirable.

  • Quality system aspects experience, including deviation management, CAPAs, complaint handling, auditing, change management, supplier qualification and batch release is desirable.

  • Ability to handle multiple tasks in a fast-paced environment with strong organisational and time management skills.

  • Must possess very good verbal and written communication skills, presentation skills, organizational skills

  • Knowledge of IT systems and software packages with strong working knowledge of Microsoft Office (Word, Excel, PowerPoint, etc.).

  • Self-driven attitude, demonstration of curiosity and innovation to drive project development forward.

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.

Other Locations:

Schedule: Full-time


Job Posting: Apr 9, 2021, 10:58:58 AM

Unposting Date: Ongoing

QA Executive Level III

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