Validation Specialist - United States
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- 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.
- 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.