Cleaning and Process Validation Specialist

2 weeks ago

Candiac, Quebec, Canada Pharmascience Full time

About Pharmascience

Pharmascience is a leading generic pharmaceutical company with a strong presence in Canada and a growing global reach. With a team of 1,500 people, we are committed to delivering high-quality prescription, over-the-counter, and pharmacist-dispensed drugs, as well as injectable medicines, all manufactured in Canada.

Our Mission

We strive to be a trusted partner in the healthcare industry, providing innovative solutions that improve the lives of patients and communities. Our commitment to excellence is reflected in our recent awards, including The Career Directory 2024, Great Place to Work 2024, and Best WorkplacesTM in Healthcare 2024.

Job Summary

The Cleaning and Process Validation Specialist will be responsible for validating manufacturing and cleaning processes for sterile products in our Candiac facility. This role requires a strong attention to detail and the ability to write reports in French and English, as well as proficiency in MS Office.

Key Responsibilities

  • Collect and review documents related to product validation, 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.
  • Plan batches to be sampled with production, and sample or supervise sampling as needed.
  • Write procedures for validation activities as required.
  • Prepare and maintain cleaning validation matrix and evaluate products to be validated.

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.

Working Conditions

  • Office work and occasional factory work in Candiac.

What We Offer

  • A collaborative, dedicated, and humane 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 with free training classes.
  • Community involvement opportunities.

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