Our client – Logistics Industry - in Mississauga is looking for a Quality Analyst Specialist on a permanent basis to join their expanding team.
What we offer:
- Location: Mississauga, but currently it is Work from Home, however it may be a hybrid 2 – 3 days in the office moving forward. Monday to Friday
- Compensation: $61,000/yr. - $65,000/yr. depending on experience
- Benefits: Health benefits, Pension Plan after 1 year, Tuition reimbursement
What you do:
- Support and maintain the Quality Management System including the Validation Master Plan for Organizational Temperature Control network.
- Execute Temperature Control Quality functions employing knowledge including but not limited to current Good Manufacturing Practices (CGMPs), corporate policies and manuals, customer Standard Operating Procedures (SOPs) and all the applicable Health Canada (HC) regulations.
- Report monthly quality metrics developed for measuring key quality attributes in temperature control network.
- Lead development and implementation of Investigation/Corrective Action Preventive Action (CAPA) process, Change Control process, SOPs, Record retention, Preventative Maintenance and Calibration records using an advance knowledge of GMPs/Guidelines 0069.
- Lead Vendor and vehicle qualification acceptance criteria. Responsible for ensuring competency of vendor/sub-contractor involved with the Temperature-Controlled validated program.
- Provide administrative support regarding document control process and records.
- Ensure consistent procedures and methods are followed in the documentation of any activities performed in association with temperature controlled validated program.
- Provide support with auditing and compliance activities, including Health Canada and Customer requirements.
- Data analysis - KPIs, deviation reporting, data automation, data visualization and presentation, etc.
Who you are:
- 4 years of industry related experience in Quality Assurance/Control or Regulatory Affairs
- Bachelor's degree in sciences, pharmacy, chemistry, or biology,
- Prior experience working within healthcare or transportation field required
- Experience using a Quality Management System.
- Strong knowledge and understanding of GMPs, ISO QMS and Health Canada Regulations on transportation
- Must be dedicated of validation of facilities, equipment, transportation activities for pharma.
- Must know to perform Gap Analysis for GDP, FDA regulations and internal SOP and processes.
- Must have extensive knowledge on the investigation and CAPA processes including excursions during transportation & Quality Metrics as required
- Good to have experience and knowledge on temperature-controlled storage and distribution, as well as transportation of pharma products
- To be creative and have knowledge on how to build and maintain quality programs related to transportation of pharma products by utilizing GUI 0069.
- Be familiar with Validation Program (IOQPQ) and experience on process validation for computerized systems, facilities, vehicles, temperature monitoring system etc.
- Experienced on maintaining Calibration and Preventative Maintenance programs as per health Canada requirements in pharma industry.
Apply now—we look forward to meeting you!
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