GMP Analytics & LIMS Specialist | Specialist GMP Analytics & LIMS | M/W/D - Referenz 001115
consult16 GmbH
Job Summary
This role as a GMP Analytics & LIMS Specialist, based near Mainz, offers the opportunity to join an internationally successful pharmaceutical company on a temporary contract until late 2027. The core responsibilities revolve around the qualification and management of reference materials within the Laboratory Information Management System (LIMS), including master data maintenance and providing first-level user support. A significant part of the job involves acting as a Key User for the document management system (GSpecS), where you will independently create, administer, and update testing regulations according to project specifications. Furthermore, you will support the development and validation of complex LIMS systems and assist project laboratories in drafting regulatory submission reports (CTAA/MAA) in English. The ideal candidate possesses a degree in Chemistry or Pharmacy, coupled with profound knowledge of GMP environments, analytical laboratory processes, and active ingredient synthesis. Proficiency in specialized systems like SAP, GSpecS, and HAL is highly advantageous, alongside excellent communication skills and fluency in English. This is a hybrid position requiring on-site presence for essential tasks and training.
Required Skills
Education
Bachelor's degree in Chemistry, Pharmacy, or a comparable field; alternatively, vocational training in natural sciences combined with extensive professional experience.
Experience
- Professional experience in analytical laboratory and GMP environments
- Deep knowledge of active ingredient synthesis and analysis
- Experience with IT systems (e.g., SAP, GSpecS, HAL)
- Long-standing professional experience (if vocational training is substituted for a degree)
Languages
Additional
- Temporary contract until September 30, 2027. Must be based in the Mainz area. Mandatory on-site presence required for training and key appointments; purely remote work is not permitted.
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