Posted on Mar 17, 2019 by Hobson Prior
Check possible quality impact on the produced batches of the IPT sterile on the basis of all available data.
Investigate "Out-of-Specification" analysis results.
Supervising investigations in case of deviations.
Adopt deviation reports initiated by production, labs and others departments.
Approving and defining corrective actions yourself to influence "Out-of-the-box
Specification "to limit analysis results and deviations.
Approve and define yourself preventive actions to repeat "Out of the box"
Specification "to avoid analysis results and deviations.
Follow-up of the timely execution of the corrective and preventive actions.
Checking and approving non-batch related documents (eg maintenance, calibration, interventions).
Create trending per product in Product Review Report
Handling complaints from the market.
Decide on proposed changes to GMP related processes (Control Of Change).
Support to various internal and external customers
Propose the order decision on batches to the Plant Qualified Person.
Inspection of batches with attention to lead times, logistical priorities and timely communication in case of potential supply problems as a result of quality-related issues
Operational knowledge of hygienic production procedures, safety regulations, operational cGMP rules and regulations.
Knowledge of management techniques Knowledge of quality techniques
Knowledge of problem-solving techniques
Diploma: Industrial pharmacist
Experience: Preferably experience with problem-solving techniques in the pharmaceutical industry or in a production environment.
Thorough knowledge of spoken and written Dutch and English
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