Spécialiste, validation nettoyage et procédés - Produits stériles

A leader in the generic pharmaceutical industry, the Pharmascience team is made up of 1,500 people 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.

Pharmascience is a privately-held, full-service pharmaceutical company with deep roots in Canada and a growing global reach, including distribution in over 50 countries.

Joining Pharmascience means joining a Canadian leader in the generic pharmaceutical industry, with a growing global reach.

Every year, our commitment to our employees is recognized. Among our recent awards : The Career Directory 2024, Great Place to Work 2024, Best WorkplacesTM with the Most Trusted Leadership Teams 2024, Best WorkplacesTM in Healthcare 2024 and Best Workplaces for Community Involvement 2023.

Summary

The Cleaning and Process Validation Specialist validates manufacturing and cleaning processes for sterile products in Candiac.

This position is directly linked to our current expansion project at our Candiac site.

Responsibilities & tasks

• Collects documents relating to the product to be validated (specifications, manufacturing sheet)
• Determines critical parameters of manufacturing processes / cleaning methods and drafts protocols and sampling plans
• Measures surfaces of production equipment, determines sampling sites and prepares sampling plans for cleaning validation
• Sends samples for analysis and coordinates with laboratories
• Receives and manages certificates of analysis
• Analyzes results and writes validation reports
• Discusses results with relevant personnel
• Manages all documentation relating to validation activities (change control, CAPA, etc.)
• Participates in problem-solving (meetings and investigations)
• Plans with production the batches to be sampled. If necessary, samples and / or supervises sampling.
• Writes procedures for validation activities, as required.
• Prepares and maintains cleaning validation matrix and evaluates products to be validated.

Skills, knowledge & abilities

• Ability to write reports in French and English; the specialist must write reports for Health Canada and the FDA.
• Good documentation skills and neat work
• Strong organizational skills
• Knowledge of statistics an asset
• Proficiency in MS Office environment

Working conditions & physical environment

Office work and occasional factory work in Candiac

Choosing Pharmascience also means

• Being part of a collaborative, dedicated and humane team striving for continuous improvement
• Being an integral part of a corporate culture that values entrepreneurship, teamwork, simplicity and self-improvement
• Have a flexible schedule with a hybrid work model : three (3) teleworking days (depending on operational needs)
• Access to a full range of benefits, including tele-medicine, from the moment you are hired
• Access to a group RRSP with employer contribution from day 1
• Take advantage of our on-site gym with free training classes
• Community involvement
Il y a 6 heures