Beschreibung
Batch Record Reviewer (w/m/d)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-organised working attitude; open-minded for new ideas and suggestions; agile, highly motivated and drive
* German native/very proficient and English good command are required
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.