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Quality Assurance Associate - Jobs in Mississauga, Ontario

Job LocationMississauga, Ontario
EducationNot Mentioned
SalaryNot Mentioned
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeFull time

Job Description

Job DescriptionWe are seeking an Associate, Quality Assurance to be based out of our Canada office. This position provides support to the DRL, Canada quality function by working with quality systems, and within established procedures in order to facilitate GMP compliance and regulations for drug products. The role is responsible for quality activities in relation to product importation and identifies/reports quality/compliance issues and ensures adherence to quality, Good Manufacturing Practice and good distribution practice.This role reports to Head of Quality - Canada and works closely with multiple functions including, but not limited to Sales, Marketing, Supply Chain, Regulatory Affairs, Third Party Partners/Vendors, Customers and Health Canada.Rolesamp; Responsibilities

  • Ensures adherence to Pharmaceutical quality, health and safety, Good Manufacturing Practice and good distribution practice and management of Quality Systems to maintain quality standards
  • Carries knowledge of quality processes, resolves routine issues that arise within the Quality Team to maintain compliance standards; escalates issues to manager for resolution
  • Understands and implements GMP regulations in relation to product release, especially activities around imported products, and handling 3PL vendors
  • Provides QA/QC support internally and coordinates interdepartmental activities with Regulatory Affairs, Supply Chain and Operations
  • Processes complaints in the Medical Information Management system and lead them to closure
  • Responsible for initiation, management and completion of QMS – Deviation, CAPA, Change Controls to ensure adequate documentation
  • Prepares and reviews Annual Product Quality Review (APQRs) and stability reports to ensure compliance to marketed products
  • Performs batch release activities by reviewing batch release documentation such as: manufacturing batch records, CoA’s, CoM’s, and all allied activities as per SOPs to ensure that Canadian GMPs are met
  • Manages the sample requests, returns, product hold and destructions process
  • Evaluates temperature data for incoming finished products and make informed decision about impact to products
  • Functions as the documentation specialist managing the Quality Assurance SOPs, including: biennial reviews, revisions, generation, etc. and oversees administrative activities for the Quality department including: filing, maintaining master documents, etc.
  • Ensures training is completed for new employees and training records are current.
  • Responsible to address issues and identify trends that help to ensure compliance, development and implementation of process improvements.

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