The use of the masculine gender has been adopted to facilitate reading and is not intended to be discriminatory.
WE ARE LOOKING FOR AN IT VALIDATION SPECIALIST...
For over 30 years, Neopharm Labs has played a vital role in the development of health products through its expertise in research and development, analytical testing, scientific analysis, and regulatory compliance. We are recognized for our commitment to industry best practices and compliance with national and international regulations.
Neopharm provides analytical services to manufacturers of pharmaceuticals, natural health products, and cosmetics. Our continuously updated quality systems ensure fast, reliable, and compliant results that meet the highest standards in both domestic and international markets.
The IT Validation Specialist, reporting to the Metrology supervisor, is responsible for validating laboratory systems by creating and implementing protocols, data integrity procedures, and master plans for validation projects.
Our Mission
To support life sciences companies — whether emerging or established — in their pursuit of medical innovation, with an approach based on:
- Rigor
- Transparency
- Flexibility
- Reliability
Key Responsibilities
- Plan, execute, and maintain the validation of GxP-impacting computerized systems, including both hardware and software.
- Develop and author validation plans and protocols (VMP, VP, IQ/OQ/PQ).
- Review and approve validation deliverables, including URS, FRS, risk assessments, protocols, and validation reports.
- Identify, document, and remediate validation deviations, including impact assessment and implementation of Corrective and Preventive Actions (CAPAs).
- Prepare validation summary reports outlining results, conclusions, and recommendations.
- Assess system changes using a risk-based approach and determine the appropriate level of revalidation required.
- Ensure data integrity compliance in accordance with ALCOA+ principles, GMP, FDA regulations, and 21 CFR Part 11.
- Maintain the validated state of systems throughout their lifecycle.
- Draft, review, and maintain SOPs and policies related to computerized system validation.
- Perform regulatory and industry guideline surveillance to remain current with evolving compliance requirements.
- Participate in internal audits, client audits, and regulatory inspections.
- Collaborate closely with IT, Quality Assurance, laboratory teams, and external vendors.
- Perform other related duties as required
Profile Sought
- More than 5 years of experience in the pharmaceutical and/or medical device industry, within regulated environments.
- Minimum of 3 years of experience in Computer System Validation (CSV) for GxP-impacting systems.
- Strong expertise in computerized system validation processes in accordance with ISPE GAMP 5, PIC/S, and ICH guidelines.
- Solid knowledge and practical application of Good Manufacturing Practices (GMP).
- Thorough understanding of Health Canada and FDA regulations.
- Proven ability to apply a risk-based validation approach aligned with international regulatory standards.
- University degree in Computer Science, Life Sciences, Engineering, or equivalent.
- Experience with enterprise systems used in laboratory and quality environments, including:
- LIMS (LabWare – strong asset)
- Computerized systems supporting GxP activities
- Strong knowledge of Data Integrity principles (ALCOA+).
- Excellent analytical and technical documentation skills.
- Ability to work independently with strong prioritization and time‑management skills.
- Strong cross‑functional collaboration and communication abilities.
- High level of attention to detail and rigor.
- Ability to perform effectively under pressure.
- Bilingual in English and French.
Why Join Neopharm?
- A growing Canadian company in the life sciences sector
- A stimulating environment focused on innovation and excellence
- High-impact projects with globally recognized partners
- A corporate culture built on quality, collaboration, and respect
- Flexible work schedule
- Dynamic and fast-paced environment that keeps you informed of the latest industry trends
- Comprehensive benefits package, including group insurance, employer-contributed retirement plan, and other attractive perks
- Employee Assistance Program and telemedicine services
- Public transportation costs reimbursed by the company
Are you ready to contribute to the life sciences industry and help improve global health?
Join Neopharm Labs, a trusted partner of leading organizations in the sector.
- Please note that your resume will be shared with the hiring manager. We thank you for your interest in Neopharm Labs Inc., but only selected candidates will be contacted.
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