Senior Visual Inspection Standards Expert (USP 1790/790)

Mantu; Quebec; Hybrid; CAD 110,000 - 160,000; Full time

Job summary

Amaris Consulting seeks an Expert Standards LMSAT, Visual Inspection to govern technical standards within a regulated pharmaceutical environment.

As the site SME for Visual Inspection, you will focus on USP <1790> and USP <790>, inspection equipment technologies, and statistical evaluation of performance, including AQL and trend analysis. Collaboration with Quality, Manufacturing, and Regulatory is essential.

Qualifications

• University degree in a scientific/technical or related discipline.
• At least 5 years of professional experience in a relevant technical field.
• Proven experience with Visual Inspection in a pharmaceutical/regulatory environment.
• Strong understanding of pharmaceutical manufacturing and Visual Inspection requirements.
• Practical knowledge of USP <1790> and USP <790>.
• Experience with inspection equipment technologies and performance evaluation.
• 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 levels.
• Autonomous, proactive, and solution-oriented approach.
• Advanced French and English, written and spoken.

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 LMSAT knowledge and capabilities.
• 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 and trend analysis.
• Facilitate the exchange of best practices between the site, other global 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.

Skills

Visual Inspection

LMSAT standards

Statistical evaluation

Regulatory compliance

Documentation

Communication skills

Stakeholder collaboration

Project management

Risk management

Bilingual French/English

Education

University degree in scientific/technical field

Tools

Inspection equipment technologies

Job description

Amaris Consulting seeks an Expert Standards LMSAT, Visual Inspection to govern technical standards within a regulated pharmaceutical environment.

As the site SME for Visual Inspection, you will focus on USP <1790> and USP <790>, inspection equipment technologies, and statistical evaluation of performance, including AQL and trend analysis. Collaboration with Quality, Manufacturing, and Regulatory is essential.