QA Specialist - Method Validation

  • Full-time

Company Description

WE ARE SGS – THE WORLD’S LEADING TESTING, INSPECTION AND CERTIFICATION COMPANY. WE ARE RECOGNIZED AS THE GLOBAL BENCHMARK FOR QUALITY AND INTEGRITY. OUR 89,000 EMPLOYEES OPERATE A NETWORK OF 2,600 OFFICES AND LABORATORIES, WORKING TOGETHER TO ENABLE A BETTER, SAFER AND MORE INTERCONNECTED WORLD. 

Job Description

  • Establish, improve and maintain lean and effective SOPs for method verification, transfer, validation compliant to current international regulatory guidelines Reviews and approves validation / transfer / verification / qualification (later described as validation) protocols and reports and related investigations.
  • Response and implement corrective actions as applicable after review of investigation reports.
  • Perform internal audits as assigned to improve effectiveness of the quality management system and follow up from audits on corrections / corrective action effectiveness.
  • Review non-conformances or Investigations related to validation (equipment, method etc.).
  • Review Secondary Standards certificates and timely release to QC laboratory.
  • Maintain CAPA program and complete effectiveness checks after following up on the completed actions.
  • Assist with implementation of electronic QMS/DMS (TrackWise) as required.
  • Approve method assessment forms provided from the client or SGS for method validation/transfer studies.
  • Participates in the regulatory audits as requested.

Qualifications

  • A minimum of a BSc degree (or equivalent) is required;
  • Over three years of related experience;
  • Previous experience in verification / transfer and validation of methods is required;
  • Previous experience in a Quality Assurance related role would be preferred;
  • Must be able to prepare compliant to regulations protocols and reports;
  • Must be capable to notice any GMP deficiencies in reports;
  • Candidates must be proficient in using various type of computer software (Word, Excel, Outlook etc.);

Additional Information

SGS Canada is an equal opportunity employer and we are committed to achieving greater accessibility by providing accommodation for people with disabilities during our hiring process.  Accommodations are available on request for qualified candidates during each stage of the recruitment process.

Please note that candidates applying for Canadian job openings should be authorized to work in Canada

 

Privacy Policy