Quality Assurance Associate

Apollo Health And Beauty Care•Toronto, ON

1d•CA$52,000 - CA$60,000

About The Position

The Quality Assurance Associate participates in the completion of milestones associated with specific projects and supports ongoing Annual Product Reviews, Management of Deviations, CAPAs, Change Management, SOP Management, and general quality management systems responsibilities in support of the manufacture, packaging and release of commercial products.

Requirements

Minimum 5 years of GMP-related experience in biopharmaceutical or pharmaceutical manufacturing.
Bachelor's degree or diploma in Chemistry, Biology, Engineering, or a related field.
Strong knowledge of cGMP/GDP requirements, international regulatory compliance, and GMP operations.
Proven ability to prioritize tasks and meet internal and external customer needs in a fast-paced environment.
Experience supporting Quality projects, including data analysis and evaluation of identifiable factors.

Responsibilities

Completes APR reports in accordance with the schedule, gathering information available from batch records, investigations, product changes, complaints etc.
Collaborate and liaise with business to review and manage Change Control Requests. Ensures GDP and change management procedures are followed.
Assists with monitoring all internal QMS compliance through performing internal audits, including production, facilities, validation, and the laboratories.
In collaboration with Quality colleagues identifies areas for continuous improvement within the QMS.
Acts as Subject Matter Expert (SME) for Investigations & Quality Risk Management.
Reviews deviation and investigation records, includes tracking, follow-up, and reporting/trending. Ensures GDP and deviation procedures are followed.
Reviews Corrective and Preventative Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness.
Works with all departments to guide the timely completion of Deviations, CAPA, Corrective Work Orders, Change Controls, and Investigations.
Helps the Compliance Specialist with the review of batch records for product release.
Generates and maintains Quality Assurance and QMS standard operating procedures (SOPs).
Oversees controlled document and system changes and performs detailed impact analysis to ensure all necessary GMP and qualification action items have been added to the change controls, as well as executed.
Collaborates significantly with cross functional groups, including Quality Assurance, Manufacturing, Process Development, Facilities, and Regulatory Affairs on quality assurance matters.
Cross-train with other QA Associates.
Responsible for Logbook issuance, control, and review.
Files and maintains controlled documents.
Other duties as assigned