Switzerland Job Openings
Lonza
QC Senior Scientist technical support and Equipment qualification 80-100% (m/f/d)
Stein
October 2, 2024
Located in Stein, Switzerland our successful CDMO Business Unit Drug Product Services (DPS) currently offers exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the position as Senior Scientist QC Equipment Qualification for a new sterile Drug product facility to support quality control related activities.
Key responsibilities:
- Lead and manage the initial and re-qualification of analytical equipment as per defined procedure
- Execution of performance qualification and act as a trainer for defined equipment and related processes
- Author, review and approve documentation (qualification plans and reports; documents from service providers) related to laboratory systems as required, following applicable SOPs and all current documentation practices.
- Ensure compliance of laboratory systems according to c GMP and current best practices and regulatory guidelines as well as respective SOP`s.
- Authoring of c GMP documents e.g. procedures (SOPs) or quality records (Deviations, Change requests)
- Oversight and guidance for proper maintenance and qualified state of equipment; Performing period review of qualification/calibration of analytical equipment
- Act as system owner for defined Equipment
- Participate as Subject Matter Expert in audits and inspections
- Apprenticeship or academical degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field
- Experience on current requirements / standards related to instrument qualification and corresponding documentation in pharmaceutical industries and c GMP controlled environment
- Broad experience in analytical methodologies like e.g. HPLC, ICief, UV-VIS, Elisa, CE-SDS etc.
- Fluency in written and spoken English, German is an asset
- Capability to work independently and in a dynamic & fast-pacing project environment
- Knowledge of lab quality systems like LIMS, Tiamo or Empower/Chromeleon
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
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