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.

Qualifications :

• 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 :

• Leadership

• Rigor et discipline

• Analytical and critical mindset

• Able to manage several projects

• Perseverance

• Humility

What company offers :

The main advantages offered are as follows:

• Competitive wages

• Group insurance

• Professional insurance

• Remote work, according to the customer needs

• Vacations: 3 weeks

• Paid sick leave: 3 days

• Monthly transportation fees

• Career advancement opportunity

• Continuing education