Overview

PharmaScience Process validation specialist – thrid party Full Time in Montréal, QC

PharmaScience

Branch Montréal QC CA

Position:
Process validation specialist – thrid party
Location:
Montréal, QC

Education and Training. Perform process validation (manufacturing and packaging) at Third Party companies….

  • Perform process validation (manufacturing and packaging) at Third Party companies.
  • Revise et approve validation documentation provided by external companies.
  • Perform due diligence for validation. Establish the validation risk and make recommendations.
  • Organize external validation activities

Collect all necessary documentation in order to validate a product (specifications, masters)
Determine validation critical parameters and strategies (according to risk level). Issue and/or revise/approve validation protocols and sampling plans
Send validation samples and coordinate activities with laboratories
Receive the certificates of analysis (database entry and classification)
Compile and analyze the results. Issue and/or revise/approve validation reports.
Discuss results with the appropriate persons and circulate the information, when needed, with production, QA, etc. Evaluate and comment investigations or deviations that occured during validation lot.

  • Manage all validation related documentation (change controls, CAPA, etc)
  • Participate and prepare meetings, when needed (NPPMP, Stage gate, Site change, Problem Resolution, Investigations, etc)
  • Follow up on validation lots with the planner or deal directly with the Third Party
  • Keep the project managers, the planners or the QA well informed on the validation status and/or the evolution of issues/challenges
  • If needed, explain the PMS sampling plan to the Third Party
  • Manage all the activities related to validation statement requests
  • If needed, is involved in the emission of procedure related to validation activities
  • Keep the different validation databases up to date.

Education and Training

  • Bachelor degree or master in science and/or engineering

Experience

  • Preferably 1-2 years of experience in validation or a
  • Minimum experience in the pharmaceutical industry.
  • Experience with sterile processes.

Skills, Knowledge and Abilities

  • Strong writing skills (french and english)
  • Good skills for meticulous documentation
  • Excellent sense of organization
  • Statistical knowlegde (valuable asset)
  • Good knowledge of windows environment
  • Dynamic and autonomous

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Employment Type: Full Time
Location: Montreal, QC, CA
Posted on: 2015-08-18
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