Compliance & Regulatory Readiness
Act as Investigator for deviations and assigned Change Controls.
Author, review, and update GMP documentation.
Perform gap assessments and support the definition and execution of remediation actions.
Actively support inspection and audit readiness for health authorities and customers, including participation in inspections and audits.
QC Equipment & System Support
Serve as Subject Matter Expert (SME) for QC equipment maintenance.
Coordinate and oversee maintenance activities for QC laboratory equipment.
Support qualification and re-qualification of existing and new QC equipment.
Support the lifecycle management of QC systems (equipment and applications)
Laboratory Support & Troubleshooting
Provide expert support to QC laboratories in the event of deviations, OOX / OOS investigations, Change Controls, and technical troubleshooting.
Collaborate closely with QC, Engineering, IT, and Quality functions to ensure robust and compliant solutions.
Who We Are Looking For
Education
Bachelor’s or Master’s degree in Molecular Biology, Chemistry, Biochemistry, Chemical Engineering , or a related scientific discipline.
Equivalent professional experience may be considered in lieu of formal education.
Experience
Minimum 5 years of experience in a GMP-regulated laboratory environment .
Strong hands-on experience with analytical laboratory equipment, including maintenance coordination.
Proficiency in technical English, German is an advantage.
Skills & Competencies
Strong commitment to quality, compliance, and data integrity .
Highly detail-oriented with a structured, risk-based approach to problem solving.
Ability to work independently while collaborating effectively across cross-functional teams.
Excellent communication, organizational, and prioritization skills .
Strong interest in digitalization and modernization of analytical systems .
High level of motivation to continuously develop technical and regulatory expertise .
Senior Scientist Compliance and Maintenance Support Quality Control • Lengnau, Switzerland