Process Improvement Specialist
6 days ago
Job Overview
We are seeking a skilled Process Specialist to join our team. As a key member of our organization, you will be responsible for ensuring compliance with global policies and procedures.
Key Responsibilities:
- Drive compliance of regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities.
- Design and author qualification documentation in line with standard processes.
- Lead experimental design of studies, execution, data analysis, and interpretation.
- Interpret trends observed in commercial process monitoring and identify areas for improvement.
- Support the execution of development and PPQ batches, change control management, and implementation.
- Lead multidisciplinary teams for process improvement and troubleshooting.
- Participate in audits and inspections.
- Lead site initiatives to improve compliance status and operational efficiency.
Requirements:
- Bachelor degree in a scientific or engineering field.
- Minimum 5 years of relevant post-degree work experience in GMP Manufacturing.
- Prior experience in drug substance process development, process characterisation studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory CTD sections, and working with external contract organizations.
- Knowledge of process monitoring systems, automation systems, operational intelligence & data systems within a GMP manufacturing environment.
- SME in upstream/downstream processing and process control strategies.
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