Compliance Auditor

Found in: Talent CA C2 - 2 weeks ago

Toronto, Canada Brevitas Full time
Resolute Workforce Solutions (Staff augmentation subsidiary of Brevitas Consulting Inc.) is dedicated to helping organizations achieve tangible results and lasting improvements via successful project delivery, continuous process improvement, and effective management of change. Our expertise is in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Project Management. We are looking for a highly motivated and energetic professional to join our team as a Compliance Auditor  in the GTA, ON .This is an on-site position. Responsibilities: Conduct internal, external and client Good Manufacturing Practices (GMP) audits. Perform internal Good Manufacturing Practices audits of all departments as required and prepare written reports to document the findings. Participate in the site Fit and Finish Audit. Facilitate site preparations and execute audits for clients and regulatory inspections including regulatory awareness programs for each agency. Assist with ongoing guidance, training of auditors and regulatory requests.
Manage Audit Observations and Audit CAPAs Provide administrative support for ongoing Compliance projects. Maintain a safe working environment and report potential hazards. 
Qualifications: Bachelor's degree in Science with 3+ years of Good Manufacturing Practices / Good Lab Practices auditing experience in the pharmaceutical, biotechnology and/or any GMP environment.
Knowledge of HPBI/FDA compliance.
Proficient with quality investigation tools – FMEA, Fishbone, etc.
Familiar with SFLMS and managing GMP regulatory requests.
Experience with SAP.
ISO13485 certification is a plus. To Apply: Click the “I’m interested” button below, or E-mail your resume in MSWord or pdf format to with the following details in the e-mail's Subject Line: Compliance Auditor : FIRST NAME, LAST NAME. We thank all applicants in advance; however, we will only contact the candidates whose qualifications match closely to the job welcome and encourage applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection our for more information.

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