Batch Record Reviewer (w/m/d)

Switzerland  ‐ Vor Ort
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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.
Start
12/2021
Von
Real Staffing
Eingestellt
19.11.2021
Projekt-ID:
2253990
Vertragsart
Freiberuflich
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