Quality Engineer

Summary
Join Us on Our Mission

As we continue to embark on this journey, we are always looking for talented, growth-minded, and passionate individuals to join us on our mission for good.

Your Contribution
Support product, process and facility development and validation activities using Advanced Product Quality Planning, Statistical Quality Control, etc.
Drafting protocols for qualification of equipment and validation of processes
Identify Critical Quality Attributes and Critical Process Parameters necessary for products in a GMP Regulated environment.
Review equipment, facility and process records and systems based on regulatory requirements to ensure compliance with procedures and regulations
Assist in defining metrological requirements of process equipment.
Assist in manufacturing or quality process improvement opportunities and design control project follow-up or design reviews and provide technical input and assistance
Work collaboratively with other functional groups to support initiatives; provide expertise for design and engineering projects and other projects as directed
Administer and enhance the engineering change process, part approval process and supplier evaluation process
Contribute to the continuous improvement of internal processes and procedures specifically by improving design control processes and procedures
Development or revise CAD drawings when required for validation purposes.
Follow and adhere to all given instructions including work procedures, Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP)
Strictly adhere to and observe all safety policies as outlined in the company policies and training sessions

What it Takes

Post-secondary accreditation in Engineering (Mechanical, Chemistry or Pharmaceutical), Pharmaceutical Science or equivalent is required.
Prior experience in a GMP-regulated environment is preferred; Knowledge of GMP standards (ICH, ISPE, Eudralex, CFR or FDR) and expectations in such a regulated environment is considered an asset;
Excellent computer skills including design and drafting software and previous experience with statistical software is desired;
Knowledge pertaining to metrology is an asset.

Benefits of Joining our Team

At ZYUS, we care about our people. Our total rewards package includes comprehensive benefits, retirements savings, on-going training and development……. and more

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