Quality Assurance Executive Level III (Fixed Term)
Mylan N.V.
Galway, Connacht, IRE
15d ago

For Us, It's A Mission At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the world's 7 billion people.

If you are unconventional, relentless and passionate. If you believe in doing what's right, not what's easy. If you are a doer and have a passion for serving others, we want to talk to you.

Make a Difference At Mylan, each person has the ability to make a difference. From the providers who sell and market our products, to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role.

Here's how this role will help :

  • Manage the company’s Permanent and Temporary Change Management system.
  • Maintenance of the incident report system (unplanned deviations), supplier non-conformance system and the CAPA system.
  • Manage the internal audit program.
  • Manage Customer Quality Complaints / Medical Device Vigilance systems.
  • Manage the company’s GMP training program.
  • Manage the company’s routine commercial stability program.
  • Prepare monthly / quarterly / annual KPI / Management review data and annual product quality review reports.
  • Perform detailed batch record review of finished products prior to QP / QA release.
  • Deputise for the QA Team Leader if required.
  • Make Our Values Your Values

    Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude.

    People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care.

    Here are the minimum qualifications and essential functions for this position :

  • Minimum of a Bachelor's degree (or equivalent) in a Science related discipline and 5-8 years relevant experience within a pharmaceutical company with a minimum of 2 years’ experience within a Quality Assurance role.
  • Experience of sterile manufacturing desirable but not essential.
  • Experience of all quality system aspects including : Deviation management, CAPA, complaint handling, auditing, change management, supplier qualification, and batch release.
  • Experience of TrackWise or similar electronic document management systems is highly desirable.
  • Excellent communication (oral & written) and presentation skills.
  • Ability to handle multiple tasks in a fast-paced environment with strong organisational and time management skills.
  • Experience of working with various IT systems and software packages with strong working knowledge of Microsoft Office (Word, Excel, PowerPoint etc.)
  • Proficiency in speaking, comprehending, reading, and writing English is required.
  • Why Mylan?

    If you want to be part of a global health care company that is making a difference and changing lives, Mylan may be the place for you.

    With a workforce of more than 35,000 worldwide, we can make a difference. We encourage you to visit Mylan.com to learn more about our unconventional culture, our approach to doing business and how we plan to set new standards in health care.

    Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement.

    All qualified applicants will receive consideration for employment without regard to their disability or protected veteran status.

    Mylan is an Equal Opportunity Employer, Minorities / Female / Disabled / Veteran.

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