Description

 

Auditor, Quality Assurance & Systems (RH2018-015)

Under the supervision of the Manager, Quality Assurance & System, the Auditor monitors the compliance with the Good Laboratory Practices (GLPs) at CIRION BioPharma Research Inc. The QA auditor provides to Management an assurance of quality by the reporting of observed deviations from the GLPs, SOPs and protocol.

Responsibilities

As a qualified member of the Quality Assurance & Systems Unit, the main responsibilities are to:

  • Carry out periodic inspections to monitorcompliance to protocols, SOPs and GLP principles and report observed deviations to Management and the Study Director.
  • Perform audits of the raw data records in accordance to the GLP principles, White Papers, Analytical Procedures and protocol requirements.
  • Perform audits of the reports generated at CIRION BioPharma Research Inc. to ensure compliance to the raw data and sign a QA statement when the study is finalized.
  • Participate in the review of SOPs to ensure GLP requirements and ensure compliance of the current practices at CIRION BioPharma Research.
  • Support in the continuous GLP training as well as training seminars for employees. 
  • Interact with internal clients to discuss QA observations and study related issues.
  • Support hosting laboratory inspections by external QA professionals and regulatory agencies.

 

Qualifications

  • University degree in Immunology, Biochemistry or a related fields.
  • 2-3 years experience in Quality Assurance profession in the GLP field as a QA Auditor in Bioanalytical and/or Immunology for Pre-clinical and/or Clinical studies. 
  • Excellent knowledge of the OECD and FDA regulations regarding GLP.
  • Good knowledge of statistical methods for calculation verification and good computer knowledge (Microsoft Office).
  • Membership in the SQA (Society of Quality Assurance) is recommended.
  • Ability to take initiative, to work autonomously, to be discrete, reliable and flexible.
  • Organization skills, ability to coordinate and conduct follow-ups.
  • Excellent French and English communications skills both oral and written.
     

Interested candidates should submit their resume and a letter of introduction immediately to the following address: humanresources@cirion.com with the reference HR2018-015. Competitive compensation will be offered to the candidate who meets the selection criteria.

CIRION is an equal opportunity employer. The use of the masculine is only intended to lighten the text. Only those applicants selected for an interview will be contacted.

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