QTS Validation Specialist

Meet Recruitment - New Jersey (30+ days ago)


We've just been engaged by the market leader in transdermal therapeutic systems & oral thin films to assist with a brand new role within their Quality Technical Services department, a QTS Validation Specialist, to perform activities associated with Equipment IQ,OQ,PQ’s and Calibrations, Validation Protocols and Reports.

Job Overview
  • Performs activities associated with Equipment IQ,OQ,PQ’s and Calibrations, Validation Protocols and Reports
  • Writes Validation Protocols and Reports.
  • Support Equipment Qualifications and Calibrations
  • Plan and coordinate cleaning, manufacturing processes, facilities and equipment validation activities. Support cleaning evaluations and verifications.
  • Develop validation plans and schedules.
  • Interact directly with customer on cleaning assessments, deviations, and validation strategy for assigned projects.
  • Coordinate validation activities with heads of Manufacturing and Converting/Packaging.
  • Assess regulatory impact of deviations, changes to equipment and batch records, materials and calibrations from validation perspective.
  • Analyze data and work with Project manager to solve technical problems.
Skills Required
  • BS in Scientific discipline or equivalent.
  • 4-5 years’ experience in the Pharmaceutical Industry with minimum 3 years’ experience in experience in cleaning validation, manufacturing processes, equipment and facilities validations.
  • Knowledge of validation concepts and current cGMP (21 CFR Parts 210/211, Part 820 & Part 11, ICH)
  • Experience in data compilation and review for statistical evaluation.
  • Demonstrated experience in writing and reviewing validation reports.
  • Strong computer and interpersonal skills.