Product Compliance Associate in Toronto, ON

  • Title: Product Compliance Associate
  • Code: RCI-67767
  • RequirementID: 117260
  • Location: Toronto, ON M3C 1L9
  • Posted Date: 04/19/2024
  • Duration: 8 Months
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  Job Description

Product Compliance Associate

 

Major Responsibilities: 

  • Receive and perform intake of product quality complaints (PQC, and combined AE/PQC) from any source into the Quality Complaint Handling System in accordance with current regulation and corporate procedures.
  • Monitor complaints entered in the Quality Complaint Handling System to ensure all required outreach activities/task actions are completed.
  • Follow-up with customers, as required to obtain requested information for the complaint record.
  • Ensure field samples are retrieved in a timely manner and complete timely follow-up of field sample return.
  • Manage PQC mailbox, ensuring all PQC complaints are entered on time and PQC queries are addressed.
  • Monitor POLO PQCs and ensure they are forwarded to the appropriate supplier for complaint investigation.
  • Participate in other quality activities, as required.

 

Job Knowledge Requirements:

Relevant knowledge and experience

  • A Canadian university degree in science or a science degree recognized as equivalent by a Canadian university or Canadian accreditation body.
  • Knowledge of Post NOC changes.
  • Understands principles of product change management and the impact on marketing authorization.
  • 2-3 years Pharmaceutical Quality Control/Quality Systems.
  • Understanding of pharmaceutical production processes i.e. manufacturing, packaging, and testing.

 

Core/Technical competency requirements:

  • Strong analytical thinking and knowledge of current GMPs.
  • Superior attention to accuracy and details, strong communication (verbal and written) skills.
  • Ability to take initiative and work independently.
  • Ability to interpret GMPs and application of their intent within the business environment.
  • Builds and Fosters networks and relationships to ensure collaboration and integration across all business partners.
  • Balance customer needs and business demands to move the business forward.
  • Demonstrated sound judgment in dealing with compliance risk.
  • Promotes and leverages the contribution of people with diverse ideas, perspectives and backgrounds.
  • Presents a united front by actively supporting team decisions.
  • Understands principles of product quality complaints and its impact on the business.
  • Proficient in Microsoft Office Applications.
  • Effectively learns new technologies and business processes.

 

Physical/Auditory and Visual Demands:

  • Majority of workday is spent in an office environment working on a computer.


About Rangam:

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