Validation Specialist
PerkinElmer Inc.
Vienna
vor 8 Tg.

PerkinElmer is hiring!

PerkinElmer invites applications from Validation Specialist -CSV for a year long contract in Vienna,Austria.

Support Compliance Projects and Programs

  • Design, Author, and Execute Computerized System Validation (CSV) according to GAMP 5 guidance especially on Analytical Laboratory Test Equipment and other Lab Information Systems
  • Technical Writing of Validation Documents (Risk Assessment, Validation Plan, Design Configuration / Specification, User Requirements, Functional Requirements, IQ OQ PQ, Trace Matrix, Validation Summary Report), SOPs, Maintenance Procedures, Calibration Procedures, and other instrument support documents
  • Translate technical information and requirements into qualification / validation test design
  • Contribute to the overall growth of PerkinElmer’s compliance business
  • Bachelor’s Degree; scientific background preferred
  • At least 3-5 years of pharmaceutical of FDA related validation experience
  • Good knowledge of GMPs, 21CFR Part 11, USP 1058 and other relevant industry regulations and guidance
  • Strong interpersonal skills and demonstrated ability work independently
  • Organized and task oriented
  • Excellent written and oral communication skills especially on technical topics
  • Self-directed and motivated individual who is able to operate in a rapidly changing business environment
  • Customer-oriented, conducting job function with a primary focus on customer satisfaction (internal & external) and ability to deal with customer complaints
  • Must have a strong command of Microsoft Office Word and Excel and Adobe Acrobat, Microsoft Project
  • Ability to Build consensus among team of stakeholders
  • Excellent critical thinking / analytical and problem solving skills
  • Experience with a multitude of laboratory equipment a plus
  • Lead Recruiter

    OneSource Global Lab IT Computing Services

    PerkinElmer For the Better

    Phone # : +44-2037705255

    Rachna.saxena perkinelmer.com

    https : / / www.linkedin.com / in / rachnasaxena2 /

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