Beschreibung
Batch Record ReviewerStarting Date: Asap
Duration: 3 months with possible extension for another 3 months
Location: 100% onsite
Language: German proficient, English good command
Key responsibilities
- Review of the Executed Batch Records (e.g. cleaning logs, production documentation review, temperature reports, test procedures, raw data, logbooks)
- Support batch release by ensuring the completeness of the documentation package
- Review comments added to the Executed Batch Records, clarify with the operations team and evaluate with the responsible QA Manager
- Support the initiation of deviations and investigations for Batch Record review related observations
- Collect and evaluate on a regular basis KPI data
- Write and revise SOPs in his/her area of expertise
Key requirements
- Bachelor degree or equivalent
- Previous experience in GDP and GMP regulated pharmaceutical / API industry is an advantage
- Ability to identify non-compliance and gaps from quality standards
- Structured, precise and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated
- German native/very proficient and English good command are required
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.