Senior Scientist, Equipment Qualification (m/f/d) 80-100%
Role overview
## Descrizione The actual location of this job is in Stein, AG, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.
## Mansioni - Lead and manage the initial qualification and re-qualification of analytical equipment and software in our QC laboratory (HPLC, CE, refrigerators etc.) - 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 - Ensure compliance of laboratory systems according to cGMP and current standard processes and regulatory guidelines as well as respective SOP`s. - Oversight and guidance for proper maintenance and qualified state of equipment; Performing period review of qualification/calibration of analytical equipment and act as system owner for defined Equipment - Participate as Subject Matter Expert in audits and inspections
## Requisiti - Solid work experience in the GMP-controlled Quality Control laboratory is a must - Hands-on experience in qualification of analytical instruments is a must - Apprenticeship or academical degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field - Broad experience in analytical methodologies like e.g. HPLC, ICief, UV-VIS, Elisa, CE-SDS is an advantage - Knowledge of lab quality systems like LIMS, Tiamo or Empower/Chromeleon is a plus - Fluency in written and spoken English is a must - Language skills in German is a plus - You enjoy working independently and in a dynamic & fast-pacing project environment
Description
## Descrizione The actual location of this job is in Stein, AG, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.
## Mansioni - Lead and manage the initial qualification and re-qualification of analytical equipment and software in our QC laboratory (HPLC, CE, refrigerators etc.) - 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 - Ensure compliance of laboratory systems according to cGMP and current standard processes and regulatory guidelines as well as respective SOP`s. - Oversight and guidance for proper maintenance and qualified state of equipment; Performing period review of qualification/calibration of analytical equipment and act as system owner for defined Equipment - Participate as Subject Matter Expert in audits and inspections
## Requisiti - Solid work experience in the GMP-controlled Quality Control laboratory is a must - Hands-on experience in qualification of analytical instruments is a must - Apprenticeship or academical degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field - Broad experience in analytical methodologies like e.g. HPLC, ICief, UV-VIS, Elisa, CE-SDS is an advantage - Knowledge of lab quality systems like LIMS, Tiamo or Empower/Chromeleon is a plus - Fluency in written and spoken English is a must - Language skills in German is a plus - You enjoy working independently and in a dynamic & fast-pacing project environment
