Qualification & Validation Specialist
2 weeks ago
Qualification & Validation Specialist
Location: Waterford
Duration: 12+ months
Our Team:
In the Validation Engineer role, you will be required to support new product introductions, equipment qualification, and the site requalification program. The Validation Engineer has a key role in ensuring the ongoing validation and compliance of existing and new equipment, systems, and processes. The following activities will be included as part of your role.
Main responsibilities:
- Designing, executing, and reporting on PV/Process Performance Qualifications.
- Designing, executing, and reporting on validation studies for equipment, systems, and processes.
- Ensuring validation studies are managed in conjunction with all required standards and legal requirements (Health & Safety, cGMP, construction, environmental, etc.)
- Providing technical interpretation and guidance of current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation, and depyrogenation.
- Ensuring that the validation status of equipment and systems is in compliance with cGMP at all times.
- Maintaining validation documentation through the validation lifecycle.
- Participation in external regulatory inspections.
- Support Site Change Control process.
Technical skills:
- Capable of troubleshooting validation issues associated with projects, process development, etc.
- Competent technical knowledge of pharmaceutical plants.
- Previous validation/product development experience would be highly advantageous for the role.
- Knowledge of Process Validation regulations, current process validation and technical transfer industry practices, and experience of interpretation and application of guidelines and regulations.
- Knowledge of requirements for GAMP, ISPE Baseline guides.
- Knowledge of steam and dry heat validation publications such as AAMI/ANSI, PDA, and ISO guidelines.
- Full understanding of relevant quality and compliance regulations.
- Able to execute projects to plan.
- Good knowledge of quality management systems.
- Good communication skills at organisation, team, and individual levels.
- Ability to use MS Project and SPC packages is an advantage.
- Understands KPIs for the site.
Candidates should hold appropriate RTWs for Ireland i.e. Stamp 1G, Stamp 4, Irish/British/EU passport.
For more information please apply here or contact Agnes Reena/agnes.reena@eirevo.ie Contact: 0858564199
Ref: ITC5615
Candidates must be eligible to work full-time and long-term in the location specified or currently hold a valid appropriate long-term work Visa to apply.
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