Wichtigste Eigenschaften
- Unternehmen
- swisselect ag
Allgemeine Beschreibung
We are looking to find for our client, a major actor in world-wide consumer products industry, a validation consultant able to start in September, initially for a 4 month contract with a strong possibility to prolong. Experience needed:2-5 years of experience working in a GxP environment, with at least one year of experience in leading activities on the following topics:
- Qualification of simple instruments
- Validation of Excel files
- Validation of out of the box (GAMP Cat. 3 and 4) software packages (standalone software or software used to drive instruments)
- Change management for validated systems in the categories listed above
Good level (written and spoken) in English and French is a must
Experience in managing a validation/change control effort top to bottom, writing documentation, overseeing execution, managing deviations, with light supervision
- Validation Plan/Change request
- User Requirements
- Risk Assessments
- IQ/OQ/PQ protocols
- Review of supplier documentation
- Traceability Matrix
- Validation Report/Change closure
Practical knowledge in at least one of the following fields is a plus
- Analytical chemistry using GC-MS, GC-FID and/or LC-MS instruments
- Bioanalytical assays (toxicology / mutagenicity)
- Batch release under GMP
- Validation of custom(ized) computerized systems (GAMP Cat. 5)
- Writing of quality procedures (SOPs, Work Instructions)
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