Provide front line expert support for all process-specific issues to production within one or more production steps, to ensure execution of processes on-
time, continuously improving in quality and efficiency, performed in compliance to cGMPs, SOPs and applicable guidelines.
Shop floor support :
Provide front line support to manufacturing, working with the shift teams, focusing on manufacturing each batch safely, on time, in compliance with the batch instructions and quality requirements.
Validation - execution and review of protocol / report :
Support the execution of process validations, re-validations, Annual Monitoring Batch (AMB) and short-term improvement projects, liaising with all the relevant parties at shopfloor to ensure accurate execution.
Review and assure that validation protocols and report are technically correct.
Ensure protocols are executed as intended.
Technical improvement execution :
Execute process improvements, scale-up.
Ensure that process technical batches generate sufficient process knowledge by thoroughly testing critical variables.
Primary packaging closure assessment during changes :
Evaluate and assure, in case of packaging change, that the primary packaging closure - including materials - are sufficient to ensure stability of the product and do not deteriorate quality.