Senior Scientist QC Bioanalytics

Senior Scientist QC Bioanalytics

Lonza

Visp, Switzerland

At the Visp site, we are looking for a Scientist (m/f/d). As a member of our great Quality Control team, you will be responsible for the routine execution of various biochemical methods, focusing on ELISA, qPCR, ProA and enzyme assays, while adhering to GMP and safety guidelines.

Key responsibilities:

• Preparation of qualification, calibration, maintenance plans in line with GMP and regulatory requirements. (IQ, OQ, PQ) according to guidelines and procedures. Verify proper installation of instruments (SpectraMax, qPCR, ViaCell etc.) according to manufacturer specifications and GMP standards.
• Validation of SMP Templates
• Performing ERAS and DIRAS according guidelines. Ensure all qualification data is accurate, complete, secure, and compliant with data integrity principles
• Ensuring communication with the responsible QUS, IT, QA and QC employees. Awareness of software lifecycle management, including validation, updates, patches, and version control, ensuring continued compliance with GMP requirements.
• Knowledge of electronic data capture, storage, backup, and retrieval processes to ensure compliance with data integrity principles (ALCOA+). Ability to interpret system logs, error messages, and diagnostic tools to identify and resolve software or hardware issues during maintenance and qualification
• Ensure ongoing compliance with GMP through audits and continuous process improvements. Familiarity with regulatory guidelines relating to computerized systems in GMP environments, such as FDA 21 CFR Part 11 and EU Annex 11.
• Understanding of how instruments/robots interface with Laboratory Information Management Systems (LIMS) or other relevant platforms.

Key requirements:

• Bachelor/Master in science or equivalent
• Solid experience with quality control laboratory instruments (e.g. SpectraMax, qPCR, ViaCell)
• Solid experience in the pharmaceutical industry in a GMP environment is a must
• Good knowledge of analytical instrument qualification (AIQ), as well good background of CSV (computer system validation)
• Experience and understanding with software, IT programs
• Structured, focused and well-organized working attitude. Open-minded for new ideas and suggestions, highly motivated and dynamic drive. Teamwork, as well flexibility for various tasks in technology team
• Good verbal and written communication in English