Technical Development Specialist

Flexsis is part of the Interiman Group, one of the leading providers of personnel services in Switzerland. Thanks to our solid expertise and the competences within the Interiman Group, we offer tailor-made solutions in personnel consulting.

For our client F. Hoffmann - La Roche in Basel, we are looking for a motivated and reliable (m/f/d)

Technical Development Specialist 80-100%

• Lead and manage CAPAs and actions from deviations, ensuring timely and effective implementation.
• Conduct thorough investigations of deviations to determine root causes and develop appropriate CAPAs.
• Document all CAPA activities in compliance with GMP regulations and company procedures.

• Maintain inspection readiness by continuously improving compliance processes and documentation.
• Collaboration with QC-Capability Leads (QC-CLs):
• Work closely with QC-CLs to ensure alignment on CAPA implementation and compliance improvements.
• Provide expert guidance and support to QC-CLs in addressing GMP issues and enhancing quality systems.
• Facilitate regular communication and coordination between departments to ensure consistent compliance practices.
• Quality System Improvements

• Monitor the effectiveness of implemented CAPAs and GMP actions.
• Compile and present regular reports on CAPA status, trends, and improvement initiatives to senior management.
• Ensure timely communication of compliance issues and action plans to relevant stakeholders

• MSc in Pharmaceutics, Analytical Chemistry, or a related field. A PhD is an advantage 
• Minimum of 2 years of experience working in a GMP environment with a strong focus on HPLC and GC analytics 
• Demonstrated expertise in analytical method validation, and troubleshooting 
• Strong knowledge of GMP regulations and guidelines 
• Previous experience in a leadership or project management role
• Familiarity with electronic laboratory information management systems (LIMS, LES, SAP)
• English fluent, German would be a Plus