Job Title: Quality Assurance Engineer
The Role:
We are seeking a highly skilled Quality Assurance Engineer to join our team in Waterford, Ireland. In this role, you will be responsible for supporting new product introductions, equipment qualification and the site requalification program.
You will play a key role in ensuring the on-going validation and compliance of existing and new equipment, systems and processes. This will involve designing, executing and reporting on PV/Process Performance Qualifications and validation studies for equipment, systems and processes.
Additionally, you will be responsible for ensuring validation studies are managed in conjunction with all required standards and legal requirements (Health & Safety, cGMP, construction, environmental etc.). You will also provide technical interpretation and guidance of current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation and depyrogenation.
Maintaining validation documentation through the validation lifecycle is crucial, as well as participating in external regulatory inspections. You will also support Site Change Control process.
Skill Requirements:
* Troubleshooting validation issues associated with projects, process development etc.
* Technical knowledge of pharmaceutical plants.
* Previous validation/product development experience would be 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.
* GAMP, ISPE Baseline guides.
* AAMI/ANSI, PDA and ISO guidelines.
* Full understanding of relevant quality and compliance regulations.
* Ability to execute projects to plan.
* Quality management systems.
* Good communication skills at organisation, team and individual levels.
Location: Waterford
Country: Ireland