Description

 

Auditor, Quality Assurance & Systems (RH2019-012)

CIRION BioPharma Research is looking for an Auditor, Quality Assurance & Systems. 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 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 taht the report reflects the raw data, and sign the release statement of these reports when the study is finalized.
  • Ensure consistency thoughout 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 a 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.
     

Interested candidates should submit their resume immediately to the following address: humanresources@cirion.com with the reference RH2019-012. A competitive compensation will be offered to the candidate who meets the selection criteria. Only selected candidates will be contacted for an interview. The use of the masculine is only intended to lighten the text. CIRION is an equal opportunity employer.

COMPANY DESCRIPTION
Since 1996, CIRION BioPharma Research has been offering contract research laboratory services to the international pharmaceutical industry. In our state-of-the-art facilities in Laval, we value the know how, the expertise, the innovation and the quality, proof of success for our company. For more information, we invite you to visit our website at www.cirion.com.
 

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