BrightOwl Loader Loading

Validation Specialist - United States  

Perrigo (company)


Posted on : 29 May 2017

Project Description

Job Description 
  • our company is 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, our company 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.
  • Our company 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.
  • Our company  sells its products primarily in North America and Europe, as well as in other markets, including Australia, Israel and China. 
  • Joining us 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 us 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.