Sterile Products Validation Specialist

6 days ago


Candiac, Quebec, Canada Pharmascience Full time

A leader in the generic pharmaceutical industry, Pharmascience is a privately-held, full-service pharmaceutical company with deep roots in Canada and a growing global reach.

As part of our team, you will be involved in the production and marketing of generic prescription, over-the-counter, and pharmacist-dispensed drugs, as well as injectable medicines, all manufactured in Canada.

We are currently expanding our Candiac site, and this position plays a crucial role in validating manufacturing and cleaning processes for sterile products.

Responsibilities
  • You will collect documents relating to the product to be validated, including specifications and manufacturing sheets.
  • Determine critical parameters of manufacturing processes and cleaning methods, and draft protocols and sampling plans.
  • Measure surfaces of production equipment, determine sampling sites, and prepare sampling plans for cleaning validation.
  • 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, including change control and CAPA.
  • Participate in problem-solving meetings and investigations.
Requirements
  • You must be able to write reports in French and English, as we work with Health Canada and the FDA.
  • Good documentation skills and neat work are essential.
  • Strong organizational skills and proficiency in MS Office environment are required.
  • Knowledge of statistics is an asset.
Working Conditions

This position involves office work and occasional factory work in Candiac.

What We Offer
  • A competitive salary range of $60,000 - $80,000 per year, depending on experience.
  • A hybrid work model with three teleworking days per week.
  • Access to a full range of benefits, including tele-medicine from day one.
  • Group RRSP with employer contribution from day one.
  • On-site gym with free training classes.
  • Community involvement opportunities.


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