Pharmaceutical Computerized Systems and IT Support Specialist

**About Shields Pharma Inc.**

Shields Pharma Inc. is a Health Canada approved GMP organization located in Markam, Ontario. We offer Laboratory R&D and QC testing services as well as production and formulation of certain psychedelic therapeutics for treatment of certain mental health disorders such as anxiety, depression, obsessive-compulsive disorder, PTSD and problematic substance abuse.

Our people are at the heart of everything we do. You can count on;
- Safety as it is our first core value,
- Integrity,
- Accountability,
- Continuous Training and skill development.

At Shields Pharma, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals.

We are currently looking for the following individuals to join our growing team

**Position Title**: Pharmaceutical Computerized Systems and IT Support Specialist - 2 Positions

**Reports To**: V.P. of Operation

**JOB SUMMARY**

Pharmaceutical Computerized Systems and IT Support Specialist supports all departments within Shields Pharma Inc. and is well-versed in current software and technological trends in traditional visual effects workflows, as well as next generation software, hardware and cloud services related to content creation and virtual production following internal procedures and Good Manufacturing Practices (GMP).

Pharmaceutical Computerized Systems and IT Support Specialist will provide strategic and operational leadership for all IT systems supporting production, Quality Control laboratory, Pharmaceutical Science and Technology, and Research and Development (R&D) across Shields Pharma Inc. operation. This role is responsible for aligning technology capabilities with business needs, ensuring regulatory compliance, optimizing digital transformation initiatives, and driving innovation across end-to-end to processes.

**ROLES AND RESPONSIBILITIES**(including, but are not limited to)
- Conduct implementation, enhancement and support of Agilent Open Lab CDS with ECM XT Server, Client and Instrument Configuration, Agilent Cary WinUV Server and Client, Agilent MassHunter Software for GC/MS and ICP/MS Systems, PerkinElmer FTIR Spectrum Software, Madgetech 4 secure software, and Microsoft Domain Network Server, Microsoft Dynamics 365 (D365), and other core platforms.
- Performing preventive maintenance and troubleshooting of Shields Pharma computerized controlled systems
- Maintain high system availability, performance, and data integrity across all supported platforms.
- Support lifecycle management and validation of computerized systems in compliance with GxP and 21 CFR Part 11.
- Ensure IT systems meet global regulatory requirements, including GxP, GMP, GLP, GDPR, and ALCOA+.
- Analyze user requirements and design and develop Shields Pharma Inc. Network System Architecture (NSA) and specifications.
- Collaborate with Quality and Compliance teams to ensure readiness for regulatory audits and inspections.
- Oversee governance, risk management, cybersecurity and business continuity plans across supported functions.
- Collaborate with all departments and functional teams to ensure IT goals and objectives are aligned.
- Collaborate with Operations and Quality to develop key performance indicators (KPIs) for balanced scorecard reporting.
- Ensure compliance with security requirements, including phishing awareness training, cybersecurity training as required, and onsite physical security (cameras).
- Validate all laboratory and production equipment software, including maintenance of the Computerized System Master Validation Plan, risk assessment, compliance with 21CFR Part 11 and GMP standards.
- Develop validation protocols where not provided by vendors and execute validation protocols.
- Develop and implement policies and procedures throughout the software development life cycle to maximize the efficiency, effectiveness, and overall quality of software products and information systems.
- Create SOPs pertaining to IT systems and write and review related technical documents and standard operating procedures.
- Perform all work in compliance with GMP, company SOPs, policies and regulatory and safety standards.
- Assess physical and technical security risks to data, software, and hardware
- Develop policies, procedures, and contingency plans to minimize the effects of security breaches.
- Manage all matters related to physical access to the facility and provide specific access to employees as defined by department heads.
- Ensure the maintenance of IT infrastructure, Corporate Network performance, software and computer-related hardware.
- Conduct computerized system backups and data recovery processes.
- Manage SPI Corporate Network, including user administration, network security, _etc_.
- Review and modify standard operating procedures (SOPs)
- Develop and review deliverables of the Software Development Life Cycle (SDLC), such as validation plans