Computer Validation Specialist - Pharmaceutical
SGS
Mississauga, Ontario, Canada
1d ago

Type of employment : Regular Business Line : Life Science Services

Reporting to : Manager, ComputerValidation

Location : Mississauga, ON About SGS :

Make an impact with SGS! With more than 97,000 employees and2,600 offices and laboratories across the world, SGS is a silent forceworking hard behind the scenes to deliver quality and integrity to businessesacross nine industries.

As the world’s leader in providing inspection, verification,testing and certification services, Forbes ranked the SGS Group as one of theworld’s top multinationals and one of the world’s most innovative companies.

The Dow Jones Sustainability Index has also recognized the SGS Group for itssustainability processes. In Canada, SGS employs over 2,000 team members across70 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 equalopportunity employer and we are committed to achieving greater accessibility byproviding accommodation for people with disabilities during our hiringprocess.

    Accommodations are available onrequest for qualified candidates during each stage of the recruitment process.

    Please note that candidatesapplying for Canadian job openings should be authorized to work in Canada.

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