Mylan Pharmaceuticals Inc.
Outsource Review Specialist
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
The Outsource Review Specialist will provide
Quality oversight and direction for the release of product of outsourced manufacturing and packaging sites contracted by Mylan Pharmaceuticals Inc. and to act as a liaison with companies utilizing Mylan Pharmaceuticals Inc. as a contract manufacturer and or packager.
Perform analytical data and batch record review of outsourced products.
Provide approval/rejection of outsourced products.
Coordinate the release with the Quality Department at the
Review temperature data from third party shipments.
Review stability data to support temperature excursions.
Ensure timely and effective communication regarding outsourced products with contract manufacturing and packaging sites.
Act as a liaison with all external contracted manufacturing and packaging sites.
Communicate and share issues with management.
Establish communication with the MPI Investigations group with respect to third party investigations. Maintain tracking of outsourced products and associated batch records for review by management. Maintain batch records and number of releases and number of rejections of outsourced products.
Initiate, review and revise all outsource product SOPs.
Assist in implementing new systems pertaining to outsourced products.
Establish communication with appropriate Quality groups to coordinate launch of new outsource products.
Enter batch data in LIMS and scan completed batch documentation.
The successful candidate will have the minimum of a Bachelor of Science Degree in a related discipline and a minimum of 0-2 years of experience is required. However, a combination of experience and/or education will be taken into consideration.
Must possess knowledge of
cGMPs (21CFR 210 and 211).
Must possess a working knowledge of analytical techniques and documentation and manufacturing batch record documentation.
Must possess a thorough understanding of Standard Operating Procedures.
possess excellent communication, writing, reading, comprehension, organization and computer skills.
Must be accurate and detail oriented.
Must be able to multitask and work with several products and companies simultaneously. Must be adept at independent decision-making.
Must be proficient in Excel, Word and PowerPoint.
Must have a working knowledge of Documentum, LIMS and TrackWise
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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