Pharmaceutical Laboratory Applications Support Specialist - IT

Pharmaceutical Laboratory Applications Support Specialist - IT

30 Jun
|
SGS
|
Mississauga

30 Jun

SGS

Mississauga

Company Description



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.



Job Description



Install/update/troubleshoot instrument software and malfunctions,





requires MS Windows/network troubleshooting skills

Review and pilot testing of new software and instrument systems as part of system implementations

Review and remediate non-compliance and audit issues for data integrity compliance on the computerized systems in the lab

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

Liaise with and management activities of laboratory instrument and software vendors

Develop validation protocols where not provided by vendor

Review and recommend changes to improve efficiency of automated systems



Qualifications



Education: Bachelors degree in Science, IT, Engineering or equivalent experience

Experience: Must have over 5 years administering laboratory instruments and laboratory software applications

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

Experience in instrument software setup, configuration and qualifications in a GxP / biological laboratory environment.

Experience in troubleshooting Windows and network related issue with instrument software configurations

LIMS Systems administration and configuration

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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