Job Description

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 96,000 employees operate a network of 2,700 offices and laboratories, working together to enable a better, safer and more interconnected world.

• The role is based in Mississauga, supporting all NAM HS locations.
• Ensure the IT Change Control process for validated systems to ensure the process is followed consistently and in compliance among the IT CSV team
• Work with NAM IT CSV team for scheduling and execution of periodic review for validated systems and Excel spreadsheets
• CSV Primary person to provide and maintain GMP compliance documents required during client/FDA/HC audits and follow-ups.
• Continue to stay abreast on the new regulations from FDA/Health Canada and EMA Annex 11
• Responsible for commissioning, maintenance and validation of all IT laboratory systems in the GMP environment according to 21CFR Part 11 throughout the life cycle of the software use (SDLC).
• Act as back up for the Administration and support of all LSS laboratory systems, scientific applications and data systems. Work with Software vendor(s) to configure laboratory systems to ensure Data Integrity compliance.
• Participate in generation of SOPs and research for efficient electronic solutions to improve laboratory processes, such as E-review in Empower and ELN solutions.
• Maintain tracking and scheduling of activities required for compliance including audit trail reviews, system archival, user review and others.
• Work closely with Management to plan, track and monitor progress of validation projects and activities and provide update to stake holders
• Lead in the Risk assessment of systems including the DRP for all the systems the incumbent must be capable of multi-tasking to provide support for legacy and new laboratory software applications while working together as a team player with laboratory personnel and Department Heads on a regular basis
• Provide support to management to stay audit ready for local LSS locations

• Data integrity and compliance to 21CFR Part 11, GxP, MHRA and European Annex 11 standards
• Review and remediate non-compliance / client / regulatory audit issues and actively participate/respond during the site audits
• Keep the binders/system updated for Change controls and validation management including annual periodic review of GxP systems
• MVP for software - Maintain and manage instrument software versions and releases as required per Data Integrity regulations and complete system configurations to ensure compliance with the SOPs and DI guidance(s)
• Participate in strategy sessions to provide solutions for the laboratory to improve efficiency and stay in compliance
• Training and communication of release information to local users
• Develop validation protocols for intended use rather than purchasing vendor packages
• Validation of all laboratory and instrument software including maintenance of the Master Validation Plan, functional requirements, risk assessment and execution of validation protocols to meet regulatory compliance and company best practices for equipment and software
• Train new staff Validation of Excel spreadsheets and other laboratory working documents
• Liaise with and management activities of laboratory instrument and software vendors
• Troubleshoot and communicate instrument system malfunctions
• Review and recommend changes to improve efficiency of automated systems such as LIMS/ELN systems
• Maintain tracking systems for all requests and incidents
• Review and pilot testing of new software and instrument systems as part of system implementations
• Lead small scale projects according to Project Management methodology and Internal SOPs.
• Provide systems guidance, direction, setting priorities and system services to SGS Life Science Services Analytical Laboratories in projects
• Stay abreast on the regulations regarding equipment/software and implement changes before regulatory deadlines. Recognize and identify potential areas where existing policies and procedures require change, or where new ones need to be developed
• Prepare draft and final SOPs and compliance documents
• Review global SOPs after revision and revise internal SOPs within 2 months from release of Global SOP if needed.
• Perform additional duties as required and reporting to Manager

Qualifications

• Education: Bachelor of Science degree in Chemistry, Biochemistry, Biology, Microbiology or related biological science or equivalent in job experience.
• Experience: Over 5 years\' experience in the use of laboratory instruments and software applications.
• Minimum of 4-5 years relevant software validation experience in a regulated industry is preferred.
• Experience working in a regulated Laboratory environment or pharmaceutical company, but also with implementation and support experience with laboratory systems/software and instrumentation. This include the LIMS software and various chromatography data.
• Preferred experience includes the pharmaceutical laboratory systems such as Empower and/or Open Lab CDS systems, Agilent, Waters, ThermoFischer with typical instrumentation such as GC, HPLC, ICP-MS, MS/MS, Spectrophtometers, FTIRs
• Experieince in instrument configuation and qualifications in a GxP / biological laboratory environment.
• Working knowledge of GxP regulations and regulatory standards for computer systems validations
• Well organized, autonomous and able to deliver good quality work efficiently
• Able / willing to prepare weekly reports of activities completed and follow directions from management including priorities
• Technically competent in Information Technology
• Ability to learn quickly in a challenging environment.
• Thorough knowledge of scientific principles pertaining to analytical records reviewed
• Ability to interpret, analyze data and draw logical conclusions required.
• Ability to troubleshoot analytical problems as needed to minimize down time.
• A willingness to review new analytical records, instrumentation and procedures.
• Software and Excel sheet validation experience
• Must be highly organized and able to work effectively and efficiently in a demanding environment with flexibility to changing priorities.
• Ability to work well with others, independently and fostering teamwork throughout the laboratory
• Proven time management skills
• Ensures full compliance with the company\'s Health & Safety, Code of Integrity, and Professional Conduct policies.
• Fluent oral and written English to be able to communicate with the other implementation teams
• Applies judgment and acts according to the SGS standards of ethics and integrity
• Candidates must be proficient in using various types of computer software (Word, Excel. PowerPoint & Outlook, LIMS, Empower, and other equipment software).
• Proven ability to manage and coordinate multiple projects in a fast-paced, highly professional environment.
• Extended hours and shift work may be required from time to time.
• Travel to other SGS locations or client location may be required from time to time.
• Must be able to read, understand and follow work instructions in a safe, accurate and timely manner.
• Candidates must be proficient in using various types of computer software (Word, Excel. PowerPoint & Outlook).
• Proven ability to manage and coordinate multiple projects in a fast-paced, highly professional environment.
• Candidates must demonstrate excellent verbal and written communication skills including grammar and composition.
• Proven time management skills and a strong attention to detail.
• Works well under pressure.
• Ensures full compliance with the company\'s Health & Safety, Code of Integrity, and Professional Conduct policies.

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.

SGS