Senior Scientist QC Bioanalytics

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.

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of!

• 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