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: Responsible for the Pharmaceutical and Medical Products Quality Assurance (QA) Operations Departments. Provide leadership to the Quality Assurance Operations departments and assures the development of personnel and systems to assure compliance with cGMP and Mylan Policies and Procedures. Ensure MTI’s compliance with cGMP regulations and all other regulatory guidelines. Perform job functions in accordance with all applicable Standard Operating Procedures (SOP), federal and state laws, Occupational Safety and Health Administration (OSHA) guidelines, health authority regulations, and departmental processes. Provide leadership for the Pharmaceutical and Medical Products Quality Assurance Operations Departments. Responsible for monitoring and assuring the compliance to all appropriate regulations and guidelines (cGMP, ISO, ICH, etc.) by the Pharmaceutical and Medical Products divisions. Evaluate existing Quality Systems and provide leadership and guidance for implementation of new systems and system improvements as indicated. Develop quality initiatives associated with the Quality Assurance Operation function designed to promote efficiency and effectiveness and assure compliance with cGMP and Mylan Policies. Analyze risks and recommend prioritization based on considerations of business needs, organizational benefits, compliance risks, and available resources. Assure written procedures are developed to describe the critical functions performed by the QA Operations departments and that the procedures are appropriate and agree with current practice and cGMP. Train and develop departmental personnel. Insure training and mentoring of MTI personnel in matters related to Quality. Maintain the systems for in-process and final product release, investigation of deviations and non-conformances, manufacturing investigation of customer complaints, annual product review, CAPA management, retention samples. Maintain the annual product review system. Assure annual reviews are completed in accordance with written procedures. Review and approve written procedures, raw material and product specifications, and master production and control records. Review and approve protocols and reports (development, clinical, process/product validation, IQ, OQ, PQ, cleaning, etc.) as required. Lead/participate in the investigations of deviations, complaints and adverse trends as necessary. Function as official company representative during FDA/MCA and vendor audits. Perform other duties as assigned. 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 qualifications for this position: Minimum of a Bachelor of Science Degree and a minimum of eight years of experience is required. Minimum of a Master of Science Degree and a minimum of six years of experience is required. However, a combination of experience and/or education will be taken into consideration. Must possess an in-depth knowledge of Quality Systems within the pharmaceutical industry along with significant experience in effecting continuous improvement, issue and personnel management. Must have working knowledge of Quality systems for the Pharmaceutical Industry, cGMP, ICH and Pharmacopoeia (USP, EP) requirements. Must possess knowledge of familiarity with computers and various software such as MS Word, MS Excel, MS Access and MS Project. Must have good working relationship with co-Workers and Management personnel and strong supervisory and leadership skills Ability to write, review and maintain QA Standard Operating Procedures and other related documents Position functions autonomously. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Good organizational skills for tracking and reporting duties are required Basic computer skills Excellent communication and Writing Skills 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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