Quality Assurance – Auditor

Currently we are looking for an experienced Quality Assurance Auditor. This person will be responsible for periodically testing and assessing the quality control systems to ensure that Deciem is up to internal and external standards.

Etobicoke

What are we looking for?

Currently we are looking for an experienced Quality Assurance Auditor. This person will be responsible for periodically testing and assessing the quality control systems to ensure that Deciem is up to internal and external standards.

What would you be doing?

  • Prepare a risk-based annual internal audit and external audit schedule.
  • Perform internal audits of areas identified in the approved internal audit schedule and assess their compliance with internal policies/procedures.
  • Perform vendor qualification audits on raw material and packaging components supplier.
  • Document audit findings in a detailed written report, assign risk classification (critical, minor or major) for all findings, and provide compliance assessment for the area/system/process audited.
  • Timely approval of audit report, compile audit finding responses, review and approve the audit report.
  • Maintain audit files and findings database for tracking to closure purposes.
  • Review approve and close internal audit related CAPAs to ensure that the completed actions appropriately address findings.
  • Review and approve departmental Self-Inspection reports.
  • Maintain departmental Self-Inspection reports database and files.
  • Maintain departmental Self-Inspection reports database and files.
  • Perform other internal system compliance assessment/audit as required.
  • Provide regulatory assessment support.
  • Work independently or collaboratively with all departments to ensure internal audits related activities are completed within the required timelines.
  • Perform new hire GMP Training.
  • Responsible for coordinating and ensuring the completion of Annual GMP and GDP training company wide.
  • Coordinate all activities training program.
  • Maintain training records where applicable.
  • Ensure existing roles training curricula are current with department manager.
  • Assist and organize other necessary trainings as requested by department managers.
  • Coordinate Quality Council and Metrics activities for Quality Management.
  • Prepare monthly training metrics.
  • Responsible for maintaining training and procedures current.
  • Collaborate with department managers to develop and prepare the training curricula for new roles.
  • Support regulatory inspections and clients audits as assigned by Quality Management.
  • Performs additional duties as assigned by Quality Management and as required to support business requirements.

What skills and qualifications do you need?

  • University degree or equivalent in Science or related area.
  • 7 - 10 years of experience in Quality Assurance out which 4 years would be in Auditing filed.
  • For Supplier Qualification System: Previous experience in auditing, supplier management, quality systems, and certification in auditing.
  • For Internal Audits: Previous experience in auditing, auditing principles, and certification in auditing.
  • For Document Management: Advanced knowledge of Microsoft Word, Excel, PowerPoint, Adobe Acrobat, and programming Macro.
  • Track record of compliance achievements.
  • Required knowledge of cGMPs guidelines, Health Canada, FDA, EMEA requirements.
  • Regulatory experience for license registrations.

Still interested?

Kindly send us your resume to vt@deciem.com. We really appreciate your effort in applying to this position. However, only those candidates who have been shortlisted for interviews will be contacted.

And the serious stuff:

DECIEM is an equal opportunity employer. We prohibit discrimination based on age, color, disability, national origin, race, religion, sex, sexual orientation, and any other legally protected class in accordance with applicable federal, provincial and local laws. We are also committed to creating and maintaining an inclusive and accessible workplace. If you are contacted for an interview and require accommodation during the interviewing process, please let us know.
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