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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.

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

Please email your resume

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