Mylan Pharmaceuticals Inc.
Senior Specialist - Quality Investigations
Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry’s broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world’s largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information, please visit
We are currently recruiting for 2 Senior Specialists for the Investigations group. The Senior Specialist will have an active and support role in giving guidance and direction in manufacturing and quality investigations conducted within the manufacturing and quality environment. This is done to ensure manufacturing adherence to FDA regulations, regulatory requirements, cGMP compliance, and SOP's. Employee is responsible for reviewing investigational reports in order to ensure that appropriate steps have been taken throughout the investigation and that all information regarding the investigation are accurately and correctly documented. Additional responsibilities will include conducting the final review of minor manufacturing investigations as well as Incident Reports.
onduct the initial review of Major and Critical manufacturing investigations.
Attend and represent Quality investigations during meetings involving processing supervisors (Production, Packaging, Label Control, etc.) and other Senior Management.
Aid in compilation of the Monthly Metrics.
Revise and review Standard Operation Procedures that are related to the Manufacturing Investigation System.
Provide Training to personnel on appropriately documenting IR’s.
Review Rejections and Develop TrackWise Reports for site needs.
Ensure all batch records are appropriately documented with correct investigation references.
Lead regular meetings dealing with Investigations, CAPAs or process improvement strategies.
Coordinate CAPA plans due to deviations which occur in the GMP area.
The successful candidate will have the minimum of a Bachelor's of Science/Arts degree (or equivalent) and 0-2 years of experience. However, a combination of experience and/or education will be taken into consideration. Must possess knowledge to understand and adhere to Company and departmental policies and procedures as well as government regulations. A background knowledge in pharmaceutical science or chemistry is advantageous. Knowledge of basic pharmaceutical manufacturing processes is also advantageous. Must possess excellent organizational and deductive reasoning skills. Excellent writing and communication skills are required. Familiarity with FDA regulations and GMP requirements are preferred. Must be detail oriented and have proficient computer skills (MS Excel, MS Word, Lotus notes, Trackwise, SAP). Familiarity with Manufacturing, Regulatory Affairs, Quality Assurance and Quality Control environments is advantageous.
At Mylan, we are not satisfied with anything less than being the best. As one of the world's leading generics and specialty pharmaceutical companies, the key to our success starts with a relentless drive to set the highest industry standards in everything we do. It takes exceptional people working together to achieve excellence. As a team, we earn our customers’ trust and loyalty by placing a high premium on always doing the right things in the right way.
Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. Mylan is an Equal Opportunity Employer, M/F/D/V.
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Feb 19, 2013, 8:28:35 AM
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