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Quality Assurance/Batch Record Review

m/w/d, Wallis

You will be responsible for reviewing executed electronic and/or manufacturing protocol for compliance to GMP and and supporting implementation/ revision of manufacturing protocols for GMP manufacturing.

Duration: Until 3 May 2025/possible extension

Key responsibilities:

Review of the executed electronic Batch Records (e.g. cleaning logs, production documentation review, temperature reports, test procedures (HEPT, FIT), Autoclave and Washing machine protocols, used material, calibration records, sample results recorded in LIMS, logbooks, etc.)
Review comments added to the executed Batch Records, clarify with the operations team and evaluate with the responsible QA Manager
Initiate and support accomplishment of Deviations and investigations for Batch Record review related observations
Support the initiation of CRs and TCRs
Support preparation of documentation package to enable fast release by QA

Requirements

Previous experience in GDP and GMP regulated pharmaceutical / API industry is an advantage
Ability to identify non-compliance and gaps from quality standards
Very good communication skills and interaction with all kinds of interfaces within the organization; strong team orientation
Structured, focused and well-organized working attitude
Open-minded for new ideas and suggestions; solution-oriented
Agile, highly motivated and dynamic drive
Ability to produce reliable results under stress
Knowledge of MES Syncade, DeltaV system (preferably)