Canada-Quality Assurance Associate III (Scientific)

Job title: Canada-Quality Assurance Associate III (Scientific)

Job description: Job Description
Job is remote. Bilingual (French and English)
Please find full job description attached

POSITION SUMMARY
Contribute to establishing and maintaining high quality and compliance status of all
products handled by *** to meet all Canadian cGMP regulations, as well as
corporate requirements.
KEY RESPONSIBILITIES AND DUTIES FOR THIS JOB
Coordinates with QA Coordination Call Center to obtain essential information
required to document technical complaints
Provides support to QA Coordination Call Center to meet needs of the complainant
Identifies and confirms inquiries as product technical complaints
Evaluates complaints for severity and risk to public safety.
Notifies interested departments (eg. Country Quality Head, manufacturing site QA,)
upon receipt of critical complaints.
Monitors and tracks sample receipt from complaints.
Ensures complaints are reviewed and processed within a timely fashion Prioritizes complaints for data entry and processing into the global database
Utilizes the customer service database to oversee complaint identification and
processing Interacts with both internal and external manufacturing sites regarding technical
complaints and their associated investigations
Performs QC Checks
Understands Health Canada complaint regulations for drug products and medical
devices
Performs file review and administrative closure for individual complaints
Produces trending reports
Monitors open complaint activity for each manufacturing site
Interacts with Customer Service, Medical Information, Pharmacovigilance and other
company departments/associates regarding the identification and evaluation of
technical complaints
Identifies and reports adverse events within one business day to Pharmacovigilance
Provides complaint support to other company departments including Customer
Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory,
Commercial Operations, Legal, and Risk Management
Participates on ad-hoc teams regarding product-specific complaint issues
Supports during regulatory, third party, and internal audits
Understands product specific information regarding common product complaints
Understands department process flows and complaint databases
Coordinates feedback to customers regarding complaint investigations via QA
Coordination Call Center

KEY REQUIREMENTS FOR THIS JOB
EDUCATION
B.Sc. in Chemistry, Biology or related sciences *
EXPERIENCE
Minimum of 3 to 5 years of related experience within the pharmaceutical industry.

Company: TalentBurst

Expected salary:

Location: Laval, QC

Job date: Thu, 03 Jun 2021 01:29:31 GMT