Chemical Quality Engineer (Pharmaceutical company) in Scarborough

We are hiring Quality Engineers for a leading pharmaceutical company in Scarborough.

Location: Sheppard and McCowan

This is a Temporary to Permanent position

To perform this job successfully, an individual must be able to oversee/perform each essential duty satisfactorily. Other duties may be assigned.

• Assist or lead in the identification, investigation, and implementation of CAPA.
• Assist or lead Control of Nonconforming Product process activities (e.g., MRB review/approval).
• Facilitate the execution of Risk Management activities.
• Support new product development and production (e.g., Change Control implementation activities).
• Provides support necessary for supplier controls, including but not limited to, supplier audits when necessary.
• Support validation activities for new and existing products, process and equipment and identify statistically based sampling plans for inspections and validations.
• Aid in the implementation SPC control system with Manufacturing and Quality Control.
• Establish and maintain Quality Management System procedures related to areas of responsibilities.
• Ensure compliance with cGMP, QSR, ISO13485, MDD/EU MDR, and other applicable regulations/standards.
• Participate in FDA inspections, ISO Certification and surveillance audits and customer audits.
• Identify and implement opportunities for continuous improvement.
• Collection and reporting of metrics and data as required.
• Performs other Quality Management System related duties as required.

QUALIFICATIONS

• BS degree in Engineering, Math or Science (Biology, Chemistry, Physics, Statistics, etc.) or 3 years of working experience in Quality Assurance/Control.
• Minimum of two years’ experience in a regulated industry, preferably Medical Device Industry
• Experience with CAPA processes (e.g., complaints, nonconforming product).
• Exposure to medical device regulations (including FDA QSRs, ISO13485).
• Technical aptitude (i.e. able to read and comprehend technical documentation, ability to comprehend and execute procedures, demonstrated understanding of system documentation).
• Knowledge of statistical sampling and analysis.
• Ability to communicate effectively (both written and oral).
• Familiar with the MS Office Suite, including Microsoft Visio and Project.

If you are interested, Kindly send your resume to resume2021@gc-employment.com with the subject line "Chemical Quality Engineer"