12 Month contract
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.