Senior Specialist, Auditing and Document Control

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Description 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: Prepare and conduct internal audits of the Distribution Center’s quality systems Provide quality support and facilitation to management during audits and inspections conducted by customers, government, and regulatory agencies Prepare internal audit reports and result metrics for Quality Management Review Develop documentation to support the authoring of post inspection audit response letters Develop and maintain SOPs related to the internal audit and document control program, and provide training as necessary to support the department Maintain the site’s document control system and work collaboratively with other site leads to ensure the timely and appropriate completion of revisions and mandated reviews of SOP’s and associated documentation Perform SOP user role training and develop training initiatives for new auditors added to the department Develop and track SOP metrics and identify methods for improving documentation efficiency and effectiveness. Qualifications 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: Minimum of a Bachelor's of Science/Arts degree (or equivalent) and 2-4 years of experience. However, a combination of experience and/or education will be taken into consideration. Must possess knowledge of Good Manufacturing and Good Distribution Practices as it relates to the storage and distribution of pharmaceutical drugs and medical devices Understanding of international industry rules and regulations such as MHRA, TGA, IMB, and Health Canada is desirable Must adhere to company and departmental procedures and policies Must possess good written and oral communication skills as well as interpersonal skills Must be able to use a computer and have the ability to utilize Microsoft Office applications (Word, Excel, and Powerpoint). Experience with documentation management, inventory control, and event management systems’ such as Documentum, SAP, and TrackWise is desirable. 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 20,000 worldwide, we can make a difference. We encourage you to visit 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.
Phama Job Categories: 
Quality Control

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