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:
Prepare and conduct internal audits for the entire Mylan Pharmaceuticals Inc., Morgantown, WV site. Initiate and complete the Trackwise internal audit reports for Quality Management review.
Prepare and conduct third party vendor audits for Mylan Pharmaceuticals third party business partners. Coordinate audit logistics and preparation activities. Serve as the point of contact between MPI Morgantown and the third party business partner for post audit communications.
Serve as the contact and schedule FDA raw material sampling exercises.
Assist in the preparation for and manage the document control room during Health Authority audits. Manage list of Subject Matter Experts (SMEs) utilized during Health Authority and third party audits.
Perform independent research for assigned topics as related to the FDA and EU regulations (GMP, GCP, GLP, PDMA, Q7A) including assessment of applicability and impact on systems being audited.
Provide independent review, understanding, and discussion of departmental and corporate policies and procedures with multiple levels of employees and Management. Serve as a compliance expert regarding GMP Interpretations for all levels of Management. Serve as a liaison within the many GXP departments of Mylan Pharmaceuticals to effectively establish compliant quality systems.
Provide guidance and support in the development of corrective actions based on GXP principles and current industry standards for all markets. Help with the organization and tracking for completion of Corrective Actions which come from the Self-Inspection audits.
Authoring and approval of SOPs, procedures, TrackWise Internal Audit reports and training documents.
Provide support for the Office of Global Compliance (Global Auditing) as needed.
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) and 2-4 years of experience. 5-7 years of experience highly preferred. However, a combination of experience and/or education will be taken into consideration.
Must possess knowledge of cGMP’s. Must understand and adhere to company and departmental procedures and policies.
Must posses good written and oral communication skills as well as interpersonal skills. Must also be able to use a computer. Ability to use Microsoft Office, specifically Excel and Word. Experience with Documentum and Trackwise a plus.
Ability to read and interpret complex technical documents. Ability to write comprehensive documents in a timely manner. Effective written and oral communication and interpersonal skills.
Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals. Ability to compute rate, ratio and percent and to draw and interpret bar graphs.
Ability to solve practical problems and deal with a variety of variables in situations where only limited standardization exists. Ability to interpret a variety of written or oral instructions.
Typically sitting at a desk. Some light lifting or carrying 25 pounds or less is sometimes required.
Normal office environment.
Proficiency in speaking, comprehending, reading and writing English is required.
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.