Batch Record Review

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

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
• Knowledge of MES Syncade, DeltaV system (preferably)