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Validation Specialist Allegan United States,  


Posted on : 29 May 2017

Project Description

Tracking Code 2015998 Job Description Perrigo Company plc, a leading global healthcare company, delivers value to its customers and consumers by providing Quality Affordable Healthcare Products®. Founded in 1887 as a packager of home remedies, Perrigo has built a unique business model that is best described as the convergence of a fast-moving consumer goods company, a high-quality pharmaceutical manufacturing organization and a world-class supply chain network. Perrigo is the world's largest manufacturer of over-the-counter ("OTC") healthcare products and supplier of infant formulas for the store brand market. The Company also is a leading provider of branded OTC products throughout Europe and the U.S., as well as a leading producer of "extended topical" prescription drugs. Perrigo, headquartered in Ireland, sells its products primarily in North America and Europe, as well as in other markets, including Australia, Israel and China. Joining Perrigo means joining a team that is driven and excited to make healthcare products more affordable around the globe. Our products improve our consumer’s quality of life – let Perrigo improve the quality of your career.    The Validation Specialist will be responsible for preparing and reviewing plans, protocols, reports, and studies associated with validation activities (Computer, Process, Packaging, Cleaning, and Equipment).      The incumbent will ensure that validation events occur in conformance with approved procedures and regulatory requirements.  The incumbent will coordinate the timing of validation events.  Also, this person will assess deviations and recommend corrective actions as necessary.    The incumbent will perform validation periodic reviews and revise/review master plans and standard operating procedures in conformance with operational, quality, and regulatory requirements.  The incumbent will review technical documents to ensure that validation acceptance criteria are consistent with product and process specifications. Required Skills       Required Experience Bachelor degree in Engineering, Chemistry, Computer Science, Programming, Pharmacy or a closely allied field, combined with at least one to two (1-2) years of pharmaceutical industry experience required. In lieu of a degree consideration may be given to those who hold 6+ years of progressively responsible and relevant work experience. High level of analytical skills with proven problem-solving ability, and good interpersonal skills. Experience in the interpretation and application of FDA requirements and cGMP are necessary. Working knowledge of 21 CFR Part 11 regulations applied to computer systems. Ability to write technical documents relating to applications and computer systems of medium complexity. The incumbent must have demonstrated the ability to organize multiple tasks and changing priorities to meet project deadlines. Excellent oral and written communication skills and excellent interpersonal skills are essential. Basic understanding of statistics preferred. Computer literacy is required. Job Location Allegan, Michigan, United States Position Type Full-Time/Regular

Locations

Allegan Michigan United States

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