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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