POSITION:

Quality Assurance Auditor

LOCATION:

Biovail Contract Research, Scarborough, ON

REPORTING TO:

Manager, Quality Assurance

POSITION DESCRIPTION:

• Ensuring procedures are adhered to prior to study start, during study, sample analysis and release of final report.
• Assist with the implementation and review of new and existing SOPs and complete the annual review of SOPs.
• Daily review of the departmental operations as per target dates on master schedule and QA monitoring/auditing schedule.
• Conduct facility and process audits of BCR.
• Circulate audit reports to department heads and follow-up on agreed to actions.
• Assist with the preparation, coordination and action plans resulting from regulatory inspections, corporate and/or client site audits.
• Assist in the training of BCR staff with regards to SOPs and regulatory requirements.

QUALIFICATIONS & EXPERIENCE:

• Knowledge / Qualifications:
  • The incumbent will possess a minimum of a college diploma in a technical or scientific field. Knowledge of regulatory requirements pertaining to GCP, applicable GLP, cGMP and ICH a definite asset. Proficient use of relevant computer software packages in a Windows environment (i.e. MS Word, Excel, PowerPoint). Good writing and keyboarding skills, and a strong command of the English language. Ability to interact with all departments on a professional level.
• Previous Experience:
  • One to three years experience in a QC/QA capacity, preferably in a clinical or technical laboratory environment.
• Communication:
  • Excellent verbal, written and interpersonal skills are required.

Please send your resume to jobs@biovail.com