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Tech Stack
Tools & technologiesSDLC
About the role
Key responsibilities & impact- Perform reviews and verifications of commissioning, qualification, and validation documents for clients' systems and processes
- Coordinate CSV projects for software and automated systems
- Develop validation strategies and plans
- Coordinate activities among stakeholders (IT department, SMEs, end users, quality unit, vendors)
- Perform risk analyses and define the qualification process
- Write and review risk assessments and applicable test scripts in accordance with GxP (GMP) compliance guidelines, 21 CFR Part 11, and validation procedures
- Prepare and review Software Development Life Cycle (SDLC) deliverables, such as validation plans, requirements, specifications, traceability matrices, test protocols (IQ, OQ, PQ), and qualification reports
- Execute and review qualification protocols to ensure compliance with applicable guidelines
- Participate in resolving deviations to protocols and procedures
- Review and revise Standard Operating Procedures (SOPs)
- Communicate CSV approaches and requirements during meetings and workshops
- Develop and deliver client training
Requirements
What you’ll need- Fluent in written and spoken French and English
- Strong communication and interpersonal skills
- Motivated to contribute to the company while actively learning
- Proactive and organized
- Detail-oriented
- Takes initiative
- Minimum of 2 years' work experience in the life sciences or pharmaceutical industry
- Bachelor's degree in Computer Science (security, infrastructure, software), Engineering (chemical, biomedical, biotechnology, etc.), or Life Sciences (biochemistry, chemistry, pharmacy, etc.)
Benefits
Comp & perks- Competitive base salary + bonus (based on company, team, and individual performance)
- Comprehensive insurance coverage through RBC
- RRSP (Registered Retirement Savings Plan) contributions
- Permanent full-time position
- Mobile phone plan reimbursement
- Dynamic company culture with career development opportunities
- Hybrid work policy (based on team and client needs)
- Regular company events
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
validation strategiesrisk analysesqualification processtest scriptsSoftware Development Life Cycle (SDLC)validation planstraceability matricesqualification protocolsStandard Operating Procedures (SOPs)GxP compliance
Soft Skills
communication skillsinterpersonal skillsmotivatedproactiveorganizeddetail-orientedinitiativefluent in Frenchfluent in English