Chemical Quality Engineer (Pharmaceutical company) 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.

DESIRED MINIMUM QUALIFICATIONS
 BS degree in Engineering, Math or Science (Biology, Chemistry, Physics, Statistics, etc.) or 3-3 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