QA Officer Biologics
Mylan N.V.
Dublin, Leinster, IRE
7d 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 :

  • Actively support the development and implementation of the Quality Management System at Mylan Dublin Biologics Quality.
  • Develop and maintain local Quality Systems, including SOPs, change control, investigations, CAPA, internal auditing, Vendor qualification & management, GxP documentation management, batch disposition, complaints and annual product review for commercial and / or clinical operations as appropriate.
  • Author and review SOPs and Technical Agreements in accordance with procedure, and review Third party GxP documentation in support of Quality Systems and batch disposition.
  • Support operation of the Training system, including preparing and presenting relevant training material, as required, and manage the GMP Training program and deliver GMP Induction & Refresher training.
  • Ensure compliance with appropriate regulatory guidance documents, while driving improvements in product and process quality.
  • Maintain the Manufacturing License and revise when required, and manage Third Party KPIs.
  • Support the implementation of the Mylan Operational Excellence programme through improvement initiatives.
  • Comply with company and Legislative Environment, Health and Safety Requirements.
  • Provide QA oversight of contracted Clinical Research Organisation’s including, Product Specification File generation and maintenance, review of clinical label packs, and support and execute any other duties as assigned.
  • 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 healthcare.

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

  • 3rd level qualification in science related discipline
  • Minimum 3 years’ experience within the pharmaceutical industry
  • Relevant experience in GMP / GLP environment Biologics, Clinical and / or Medical Devices an advantage
  • Background in Regulatory Affairs an advantage
  • Strong organisational skills / ability to prioritize work
  • Proven track record as a team player
  • High level of proficiency in Microsoft Word / Excel
  • Why Mylan?

    If you want to be a 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 30,000 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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