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: Assist in or perform evaluations of quality systems and practices at Mylan sites located around the globe taking into considerations national and international regulations as applicable (FDA, EMEA, TGA, Health Canada, WHO, PIC/S, MHLW, JP). Perform routine regulatory compliance surveillance activities to detect, monitor, collate and communicate global compliance trends which could impact Mylan or affiliate sites. Maintain compliance surveillance database. Assist in the evaluation of global compliance metrics to determine trends and opportunities for continuous compliance and quality improvement. Identify potential problems and coordinate resolution to issues prior to their having an adverse effect on the established business. Provide guidance on quality/compliance improvement as needed to assure sites are always prepared for Regulatory Agency inspections. Prepare and maintain schedules, meeting agenda, and evaluation reports. Prepare executive summaries and reports based on evaluations conducted Stay current with industry standards and interpretations of key regulations. Efficiently coordinate travel in order to work within budgetary commitments while meeting global quality demands. 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: A minimum of a Bachelor's degree (or equivalent) and a minimum of four years of relevant pharmaceutical compliance/quality experience are required. However, a combination of experience and/or education will be taken into consideration. Must possess a sound knowledge of applicable cGMP regulations and expectations sufficient to readily interpret, lead discussion, and provide guidance based on the applicability of the regulations to the subject being evaluated. Must be familiar with all other GXP concepts. Must possess excellent communication and negotiating skills. Must be articulate in both written and oral communications including diplomatic discussion of required corrective actions with business partners. Must be able to review, interpret, and discuss governing regulations, precedent interpretations, and current application. Must be adept at independent decision-making. Must be proficient in leading discussions of complex topics and have a working knowledge of Microsoft Office including Word, Excel and Lotus Notes. 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 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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