Validation Specialist

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Location
Montreal
Job Type
Permanent position
Category
Pharmaceutical/Biotechnology
Job number
091636
Scolarship
D.E.C
Spoken and written languages
Français, English
Used softwares
Suite Office

Description

The Validation Associate will be responsible for providing support to validation activities by generating and execution of validation protocols and data analysis. He will also be responsible for archiving validation department documentation.

Major Areas of Responsibility: 

  • Writes and execute qualification protocols for production equipment and utilities;
  • Writes and execute process validation protocols and generate reports;
  • Perform sampling and testing during process and cleaning validation, and final bulk hold times;
  • Prepares requisitions for chemical and microbial testing;
  • Create, update and train on WI, SOP, and other necessary documents needed to perform validation work;
  • Collect, analyze and summarize test results from validation studies;
  • Participate in deviation investigations and resolutions for issues encountered during execution of validation activities;
  • Prepare binders for validation activities, scan and archive validation documents;
  • Generate the weekly production KPI reports
  • Ensures all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP and health and safety requirements;
  • Performs Quarterly Environmental Monitoring of Viable and Non-Viable Particles;
  • Perform Biannual Compressed Air Monitoring;
  • Generate report for the temperature and humidity monitoring for the warehouse area.

Specific knowledge

Education/Competencies requirements:

  • Diploma of college studies in health science or related field
  • 1 - 3 years of work experience in a regulated industry
  • Good technical writing skills
  • Organized and systems-oriented
  • Strong knowledge of MS-Office software and PC Skills required.
  • Strong interpersonal skills, team player, and flexible without compromising quality
  • Ability to manage multiple projects in a dynamic environment
  • Bilingual (French/English)
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