Serialization Quality Engineer
Our client has an immediate full-time permanent opportunity available for a Serialization Quality Engineer in Montreal, Quebec
Main Responsibilities :
Without limitation, the main tasks involve:
Manage the implementation of serialization projects from conception to project closure.
Perform a risk analysis of the current state and define the serialization modalities.
Monitor technology by evaluating serialization solutions available on the market.
Coordinate or participate in the execution of commissioning activities up to validation (FAT, SAT, IQ, OQ, PQ) of the serialization project.
Write serialization protocols and reports.
Participate in the implementation of the SNMS (Serial Number Serialization System) architecture.
Participate in the creation of serialization models for the coding and maintenance of system and process data.
Perform periodic reviews of serialization activities and ensure compliance with the customer's internal quality assurance procedures (SOP).
Write, if applicable, the discrepancies encountered and follow up to implement the CAPA
Provide solutions to problems encountered and perform all tasks relevant to the mandate.
Bachelor's or Master's degree in engineering (computer science, software, automation, industrial, chemical, mechanical) or any other related discipline
1 (one) to 10 (ten) years of industry experience, preferably in the pharmaceutical, biopharmaceutical or cosmetic sector
Demonstrated experience with serialization projects in industry
Experience in Computerized Systems Validation (CSV) (an asset)
Knowledge of programming languages and database administration (an asset)
Project management (an asset)
Knowledge of Health Canada, FDA, EMA regulations (an asset)
Excellent knowledge of MS Office, MS Project (an asset)
Good writing and communication skills in English and French
Valid class 5 driver's license (an asset)
Mobility (an asset)
Personal skills :
Rigor et discipline
Analytical and critical mindset
Able to manage several projects
What company offers :
The main advantages offered are as follows:
Remote work, according to the customer needs
Vacations: 3 weeks
Paid sick leave: 3 days
Monthly transportation fees
Career advancement opportunity
Please email your resume firstname.lastname@example.org