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Instrument Qualification Expert – GMP & QA Focus - Job Opportunity at Nemensis AG

Basel, Switzerland
Contract
Senior
Posted: May 13, 2025
On-site
CHF 48-60 per hour

Benefits

Access to extensive Life Sciences industry network in Northwestern Switzerland
Professional career development support and consultation
Individual onboarding support and process guidance
Opportunity for contract extension up to 18 months

Key Responsibilities

Lead instrument qualification processes ensuring GMP compliance and quality standards
Strategic management of analytical instrument lifecycle and calibration processes
Development and maintenance of GMP management systems with database oversight
Cross-functional coordination between QA, ARD, and external stakeholders
Quality documentation development and review leadership
Training program development and implementation
Global ARD team representation in analytical initiatives

Requirements

Education

Master's degree in relevant field

Experience

5-6 years in analytics, quality assurance, and instrument management

Required Skills

GMP environment expertise Strong communication skills Flexibility and adaptability Fluent English (German advantageous) Instrument qualification expertise Quality assurance knowledge Documentation management
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Sauge AI Market Intelligence

Industry Trends

Increasing regulatory scrutiny in pharmaceutical manufacturing is driving demand for GMP expertise and qualified instrument specialists Digital transformation in lab operations is creating need for expertise in computerized system validation and electronic documentation Growing focus on data integrity and automated analytics requires specialized knowledge in instrument qualification

Salary Evaluation

The offered rate of CHF 48-60 per hour (approximately CHF 100,000-125,000 annually) aligns with market rates for senior GMP specialists in Switzerland's pharmaceutical hub

Role Significance

Typically operates within a quality assurance team of 5-8 specialists, collaborating with multiple departments
Senior technical specialist role with significant influence on quality compliance and operational excellence

Key Projects

Implementation of new analytical instrument qualification protocols GMP system optimization and compliance enhancement initiatives Cross-functional quality improvement programs Regulatory audit preparation and response management

Success Factors

Deep understanding of GMP requirements and their practical application in instrument qualification Strong stakeholder management abilities across multiple organizational levels Excellent documentation and technical writing skills for regulatory compliance Ability to balance quality requirements with operational efficiency

Market Demand

High demand position due to stringent regulatory requirements and limited pool of qualified GMP experts in the Swiss market

Important Skills

Critical Skills

GMP compliance expertise - Essential for ensuring regulatory compliance and quality standards Instrument qualification experience - Core requirement for technical success Quality system management - Fundamental for process improvement and compliance

Beneficial Skills

Project management capabilities Risk assessment expertise Digital system validation knowledge German language skills for local communication

Unique Aspects

Position combines technical expertise with quality system management
Role offers exposure to latest analytical technologies and regulatory requirements
Opportunity to influence GMP practices across multiple departments

Career Growth

2-3 years in role typical before advancement to management positions

Potential Next Roles

Quality Assurance Manager Validation Program Lead GMP Compliance Director Technical Operations Manager

Company Overview

Nemensis AG

Nemensis AG operates as a specialized recruitment firm focusing on Life Sciences sector in Switzerland

Well-established player in Life Sciences recruitment with strong client relationships
Strategically positioned in Basel's pharmaceutical hub with extensive industry networks
Professional consulting environment with emphasis on industry expertise and client service
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