Sterile Product Validation Specialist

5 days ago


Candiac, Quebec, Canada Pharmascience Full time

At Pharmascience, we are seeking a highly skilled Cleaning and Process Validation Specialist to join our team in Candiac.

About the Role

The successful candidate will be responsible for validating manufacturing and cleaning processes for sterile products. This involves collecting documents related to the product, determining critical parameters of manufacturing processes and cleaning methods, and drafting protocols and sampling plans.

Key Responsibilities

  • Collect and review product documentation, including specifications and manufacturing sheets
  • Determine critical parameters of manufacturing processes and cleaning methods
  • Draft protocols and sampling plans for cleaning validation
  • Measure surfaces of production equipment and determine sampling sites
  • Send samples for analysis and coordinate with laboratories
  • Receive and manage certificates of analysis
  • Analyze results and write validation reports
  • Discuss results with relevant personnel
  • Manage all documentation related to validation activities
  • Participate in problem-solving and meetings

Requirements

  • Ability to write reports in French and English
  • Good documentation skills and neat work
  • Strong organizational skills
  • Knowledge of statistics an asset
  • Proficiency in MS Office environment

What We Offer

  • A collaborative and dedicated team environment
  • A flexible schedule with a hybrid work model
  • Access to a full range of benefits, including tele-medicine
  • Access to a group RRSP with employer contribution
  • On-site gym and free training classes
  • Community involvement opportunities


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