Responsibilities:
- Technical support of process equipment.
- Participates in change controls and other compliance related tasks.
- Participates in the review of current and future procedures
- Analyses the results of testing and determines the acceptability of results against predetermined criteria.
- Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
- Identifies current and anticipated requirements for compliant computerised operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
- Coordinates with and guides other departments or outside contractors/vendors to complete tasks.
- Writing of protocols and Reports.
- Preparation and review of Qualification protocols (IQ, OQ and PQ)
- Provide technical support to manufacturing operations.
Experience & Qualifications:
- Third level qualification in Engineering or Science
- Prior experience with UFDF an advantage
- Prior experience in Tech Transfer and advantage
- Demonstrated knowledge of GDP within pharmaceutical industry
- 4 years’ experience in a pharmaceutical environment
- Strong problem-solving, collaboration, and written and oral communication skills.
- Proven ability to work independently Self-motivated and collaborate effectively as part of a team.
- Strong organizational, interpersonal, writing, and time management skills.
- Knowledge of Regulations and applicable standards for Quality, Safety, Regulatory
- Understating of DeltaV
If interested please contact Seán on 021-4297900 or sean.molloy@peglobal.net.
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