Description
Responsibilities:
- Conduct validation activities in compliance with US and EU regulation
- Develop and execute validation documentation as required (eg IQ, OQ, PQ plans, protocol
- Provide Technical expertise over a range of projects, such as the introduction of new equipment and improvement to current manufacturing processes etc
- Responsible for the preparation, review and approval of relevant technical documentation, risk assessments, CAPA's etc
- Co-ordination, implementation and active participation in the site validation program for processes, equipment, software, methods, utilities/facilities, cleaning and sterilization
- Ensure highest Quality & Compliance standards.
Education/Skills Required:
- Degree or 3rd level qualification (Technical, Science, Engineering, Production, Mechanical, Process, Industrial, Automation).
- Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (eg Technical, Engineering, Manufacturing, Process, Quality etc.)
- At least three years experience in the Pharmaceutical industry or a similar operating environment with experience in a Technical/Engineering/Process/Quality role in a manufacturing environment
- Successful candidates should have technical and operational experience in one or more of following disciplines
- Equipment Sterilisation/Decontamination (Steam, Dry Heat, VHP)
- Sterilising Filtration
- Aseptic Filling/Visual Inspectio
- Lyophilisation
- Technology Transfer/New Product Introduction for Steriles
- Cleaning Validatio
- Demonstrated self motivation/direction skills with a continuous improvement focu
- Demonstrated successes in a team environment, such as project teams, Six Sigma teams, CI teams etc.
- Advanced PC skills such as Excel, Word, PowerPoint.
- Demonstrated ability to prepare and execute Validation protocols
We are acting as an Employment Business.