Global Quality Auditor
Mylan N.V.
Barcelona, CT, ES
hace 1 día

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.

Responsibilities ofthis role encompass a variety of functions, such as provide objective audits ofinternal GXP systems and external businesses for Mylan Management in order toaccurately depict the status of compliance and to foster improvements based oncurrent GXP references and interpretations.

Here's how this role will help : Essential Functions :

  • Prepare and conductinternal and external audits for Mylan.
  • Perform independentresearch of required topics and FDA, EMEA, TGA, Health Canada, WHO, PIC / S,MHLW, and other national, international, or supranational regulations (GxP andICH) including assessment of applicability and impact on systems being audited.

    Provide independentreview, comprehension, and discussion of departmental and corporate policiesand procedures with multiple levels of employees and Management.

    Provide interpretationof complex regulations through research of current corporate and governmentalexpectations.

    Perform GXP internaland external audits based on a defined audit plan within specific time constraints,including the facilitation of opening and closing audit meetings with alllevels of Management, the preparation of all associated documentation includingaudit plans and audit reports under strict confidentiality, and track andmonitor audit responses and the implementation of corrective actions.

    Provide guidance andsupport in the development of corrective actions based on GXP principles andcurrent industry standards.

    Authorand approve procedures.

    Serve as a compliancereference regarding GXP Interpretations for all levels of Management.

    Serve as a liaisonwithin the many GXP departments of Mylan to effectively establish compliantquality systems.

    Plan, schedule, andarrange travel to various sites based upon guidance from Management.

    Perform other duties asassigned.

    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 for this position :

    Minimumqualifications :

  • Minimum of a bachelor’s degree in Pharmacy (or equivalent).
  • Atleast 6 years of experience GMPand / or Audit experience. However, a combination of experience and / or educationwill be taken into consideration.
  • Sterile Manufacturing and or Compliance experience preferred.
  • Mustpossess a sound knowledge of nationaland international cGMP regulations and expectations enough to readilyinterpret, discuss and provide
  • Guidancebased on the applicability of the regulations to the subject being audited.Must be familiar with all other GXPconcepts .
  • Mustbe articulate in both written and oral communications including diplomaticdiscussion of required corrective actions with business partners.
  • Must be able to review , interpret, anddiscuss governing regulations , precedent interpretations, and currentapplication.
  • Must be adept at independent decision-making.

  • Analyticalmindset paying attention to details.
  • High English level is a must , due to the selected candidate should understandtechnical documents and communicate description of problems and solutions
  • Why Mylan?

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

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

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