Expert Standards LMSAT, Visual Inspection

Expert Standards LMSAT, Visual Inspection

Location: Québec City, Québec, Canada

Work model: Hybrid, 3 to 4 days onsite per week

Address: 2323, boulevard du Parc Technologique, Québec, QC G1P 4R8

Contract options: Permanent or freelance

Language requirements: Advanced French and English, written and spoke.

About the opportunity

Amaris Consulting is looking for an Expert Standards LMSAT, Visual Inspection to support the effective implementation, understanding, and governance of technical standards within a regulated pharmaceutical environment.

The successful candidate will serve as the site’s subject matter expert for Visual Inspection, with particular focus on USP <1790> and USP <790>, inspection equipment technologies and limitations, and the statistical evaluation of inspection performance.

This role combines technical expertise, coaching, regulatory compliance, continuous improvement, and cross-functional collaboration within a matrix organization.

Key responsibilities

• Act as the site’s technical reference for LMSAT standards related to Visual Inspection.
• Provide technical expertise, coaching, guidance, and support to site teams.
• Ensure consistent and effective application of Visual Inspection standards across the site.
• Strengthen technical capabilities and knowledge related to LMSAT requirements.
• Identify, assess, investigate, and resolve technical challenges associated with inspection standards.
• Support the interpretation and application of USP <1790> and USP <790>.
• Assess inspection equipment technologies, capabilities, limitations, and performance.
• Evaluate inspection performance using statistical tools and methodologies, including:
• AQL
• False Reject Rate
• Knapp-Kushner testing
• Performance monitoring and trending
• Facilitate the exchange of best practices between the site, other global supply-chain sites, and subject matter experts.
• Support continuous-improvement initiatives related to Visual Inspection and LMSAT standards.
• Define and monitor relevant KPIs and performance indicators.
• Support projects and initiatives involving quality, regulatory, operational, and technical requirements.
• Identify risks, recommend mitigation strategies, and support timely resolution of issues.
• Prepare clear technical documentation, reports, procedures, presentations, and recommendations.
• Collaborate with Quality, Manufacturing, Engineering, Validation, Regulatory, and other site functions.
• Manage multiple priorities while maintaining accuracy, compliance, and delivery timelines.

Required qualifications

• University degree in a scientific, technical, engineering, pharmaceutical, or related discipline.
• At least 5 years of professional experience in a relevant technical field.
• Proven experience with Visual Inspection in a pharmaceutical, biotechnology, medical-device, or similarly regulated environment.
• Strong understanding of applicable pharmaceutical manufacturing and Visual Inspection requirements.
• Practical knowledge of USP <1790> and USP <790>.
• Experience with inspection equipment technologies, performance evaluation, and equipment limitations.
• Knowledge of statistical evaluation methods such as:
• AQL
• False Reject Rate
• Knapp-Kushner testing
• Experience working in multidisciplinary teams and matrix organizations.
• Knowledge of risk-management and project-management principles.
• Strong technical writing and documentation skills.
• Excellent communication and presentation abilities.
• Ability to influence, collaborate, and build relationships with stakeholders at all organizational levels.
• Autonomous, proactive, and solution-oriented approach.
• Strong organizational skills and ability to manage multiple priorities.
• Ability to work accurately in a dynamic environment with changing priorities.
• Advanced French, both written and spoken.
• Advanced English, both written and spoken.

What success looks like

• LMSAT technical standards are clearly understood, adopted, and consistently applied across the site.
• Site teams receive the expertise and support required to implement Visual Inspection standards effectively.
• Technical issues related to the deployment of standards are identified early and resolved appropriately.
• Best practices are shared effectively between the site, other global sites, and technical experts.
• KPIs and statistical indicators are used to monitor performance and support continuous improvement.
• LMSAT-related projects are delivered on time and in compliance with quality, regulatory, and operational requirements.
• The site maintains a high level of expertise in Visual Inspection.
• Inspection processes demonstrate continuous improvement through data-driven analysis and statistical performance monitoring.

Why join this opportunity?

This is an opportunity to take a key technical role within a regulated pharmaceutical environment and contribute to the consistent implementation of global standards. You will work closely with site teams, quality and manufacturing functions, global experts, and technical stakeholders to improve Visual Inspection capabilities and maintain compliance with industry best practices.