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Computer Validation Specialist - Pharmaceutical

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Information Technology
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048535 Requisition #
Type of employment: Regular
Business Line: Life Science Services

Reporting to:  Manager, Computer Validation

Location: Mississauga, ON
 
About SGS:

Make an impact with SGS! With more than 97,000 employees and 2,600 offices and laboratories across the world, SGS is a silent force working hard behind the scenes to deliver quality and integrity to businesses across nine industries. As the world’s leader in providing inspection, verification, testing and certification services, Forbes ranked the SGS Group as one of the world’s top multinationals and one of the world’s most innovative companies. The Dow Jones Sustainability Index has also recognized the SGS Group for its sustainability processes. In Canada, SGS employs over 2,000 team members across 70 locations

 
A day in the life of a Computer Validation Specialist at SGS Canada:
  • Validation of all laboratory and instrument software including maintenance of the Master Validation Plan, functional requirements, risk assessment and execution of validation protocols
  • Data integrity and compliance to 21CFR Part 11 and GxP standards
  • Prepare draft and final SOPs and compliance documents
  • CCR and validation management
  • Validation of spreadsheets and other laboratory working documents
  • Review and remediate non-compliance and audit issues
  • Liaise with and management activities of laboratory instrument and software vendors  
  • Develop validation protocols where not provided by vendor
  • Troubleshoot and communicate instrument malfunctions
  • Review and recommend changes to improve efficiency of automated systems
  • Maintain tracking systems for all requests and incidents
  • Maintain and manage instrument software versions and releases
  • Review and pilot testing of new software and instrument systems as part of system implementations

Ideal Candidate:
  • Education: Bachelors degree in Science, IT, Engineering or equivalent experience
  • Experience: Must have over 5 years  laboratory instrument and laboratory software applications experience
  • Experience should include the pharmaceutical laboratory  systems such as  Empower and/or Open Lab CDS systems, Agilent, Waters, Thermo Fischer with typical instrumentation such as GC, HPLC, ICP-MS, MS/MS, Spectrophotometers, FTIRs
  • LIMS Systems administration and configuration
  • Experience in instrument configuration and qualifications in a GxP / biological laboratory environment.
  • Working knowledge of GxP regulations and regulatory standards for computer systems validations
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.


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