GCP, Senior Clinical Auditor

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POST DATE 9/7/2016
END DATE 10/14/2016

Mylan Inc Morgantown, WV

Mylan Inc
Morgantown, WV
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Mid-Career (2 - 15 years)
Bachelors Degree


For Us, Its A Mission

At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the worlds 7 billion people. If you are unconventional, relentless and passionate. If you believe in doing whats right, not whats 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. Heres how this role will help:

* Prepare and conduct internal and external audits for Mylan.

* Perform independent research of required topics and FDA, EMEA, TGA, Health Canada, WHO, PIC/S, MHLW, and other national, international, or supranational regulations (GxP and ICH) including assessment of applicability and impact on systems being audited.

* Provide independent review, comprehension, and discussion of departmental and corporate policies and procedures with multiple levels of employees and Management.

* Provide interpretation of complex regulations through research of current corporate and governmental expectations.

* Perform Clinical internal and external audits based on a defined audit plan within specific time constraints, including the facilitation of opening and closing audit meetings with all levels of Management, the preparation of all associated documentation including audit plans and audit reports under strict confidentiality, and track and monitor audit responses and the implementation of corrective actions.

* Provide guidance and support in the development of corrective actions based on Clinical principles and current industry standards.

* Author and approve procedures and serve as a compliance reference regarding Clinical Interpretations for all levels of Management.

* Review, evaluate, and approve clinical audit reports. Serve as a liaison within the many Clinical departments of Mylan to effectively establish compliant quality systems.

* Plan, schedule, and arrange travel to various sites based upon guidance from Management.

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 Bachelors degree (or equivalent) and 6 years of Clinical Operations and/or Audit. However, a combination of experience and/or education will be taken into consideration.

* 40 percent domestic and international travel is required.

* 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 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.
Job Posting: Sep 6, 2016, 2:45:23 PM
Unposting Date: Ongoing.