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Q&R Canada Inc.
PV/QC AssociateQ&R Canada Inc. • Oakville, ON, CA
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PV/QC Associate

PV/QC Associate

Q&R Canada Inc. • Oakville, ON, CA
9 days ago
Job type
  • Full-time
Job description
Q&R Canada Inc. is looking for a PV/Quality Assurance Associate to join their team of high performers to manage the regulatory and post-market compliance activities of their partners for the Canadian region. Pharmacovigilance Responsibilities - Perform literature searches, periodic summary reports, case reporting for various clients - Prepare related documentation - Collection, processing, and reporting of complaints and adverse events (AEs); - Adhering to compliance standards in regard to reporting timelines - Electronic filing and archiving of PV documents - Creating and reviewing Standard Operating Procedures (SOPs) As a member of the Quality Control team, you will be ensuring compliance with Canadian GMPs, Medical Device Regulations related to product importation, release and distribution in Canada. - Ensure receipt of required documentation from suppliers; - Perform Batch Document, Certificate of Analysis and Certificate of Manufacture review ; - Support and follow-up of CAPA action plans, deviations and out-of-specification investigations; - Support audits with regards to the preparation, conduct and follow-up. - Sample tracking and label review; Reconcile GMP documents for product lots requiring QC disposition (Label Reviews, Batch records, Certificate of Analysis and Certificate of Manufacture,); - Coordinate required confirmatory testing and stability for imported products - Perform, analyze and interpret data trends from drug and natural health product stability programs; - Handle product complaints, including documenting complaint information as well as coordinating sample retrieval and investigation. Qualifications - Post-graduate certificate in Pharmaceutical, Regulatory Affairs, and/or Quality operations - Must demonstrate a high level of attention to detail in completion of tasks and cross-referencing of information in several logs. - Must demonstrate strong written and verbal communication skills in English. - Ability to multitask, prioritize and work effectively independently and in a team environment. - Strong organizational skills and self-motivated in completing tasks and meeting deadlin
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PV/QC Associate • Oakville, ON, CA

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