Batch Record Reviewer

Vertragsart:
Vor Ort
Start:
04/2021
Dauer:
keine Angabe
Von:
Real Staffing
Ort:
Switzerland
Eingestellt:
08.04.2021
Land:
flag_no Schweiz
Projekt-ID:
2086198


Batch Record Reviewer

Starting 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.