Description

 

Auditor, Quality Assurance & Systems (RH2018-005)

Under the direction of the Vice-President and COO, the Human Resources, Senior Consultant will be involved in the company’s human resources management activities. In partnership with Management, the individual holding this position will contribute to all HR related initiatives aligned with the company’s strategy.

Responsibilities

  • Carry out periodic inspections of studies in progress. During these inspections, compliance to the protocol, SOPs and GLP principles are monitored and all observed deviations are reported to Management and the Study Director.
  • Perform Audits of the raw data records in accordance to the GLP principles, SOPs, and protocol requirements.
  • Perform Audits of the reports generated at CIRION BioPharma Research Inc. to ensure that the report reflects the raw data, and sign the release statement of these reports when the study is finalized.
  • Ensure consistency throughout the project with the handling of data and reporting of data both within a project and within the company.
  • Complete the inspection checklists during experiment inspections and general laboratory inspections. 
  • Support in the writing of SOPs pertaining to the Quality Assurance Department, responsible for writing SOPs or revising SOPs to reflect the current practices in the Quality Assurance Department at CIRION BioPharma Research.
  • Support in the continuous GLP training for all employees, as well as training seminars for new employees as well as GLP refresher courses on a yearly basis.
  • Interact with internal clients to discuss QA observations and study related issues.
  • Support hosting laboratory inspections by external QA professionals, which may represent clients or other regulatory agencies.

 

Qualifications

  • University degree in Biochemistry, Physiology, or a related field,
  • 2-3 years experience in Quality Assurance profession in the GLP/GCP field as a QA Auditor. 
  • Experience in Bioanalytical, Immunology, Pre-clinical and Clinical studies would be an asset.
  • Excellent knowledge of the FDA regulations regarding GLP and GCP.
  • Guidance knowledge of ICH, HPB and OECD
  • 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
     

If you are passionate about the biopharmaceutical industry, and are looking to join our team in Laval; a professional, dynamic team and meet exciting challenges within a growing company, please submit your resume.

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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