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Pharmaceutical Validation Specialist
3 weeks ago
Job Overview:
The successful candidate will be responsible for designing, executing, and reporting on Process Performance Qualifications (PPQs) and validation studies for equipment, systems, and processes. They will also provide technical interpretation and guidance of current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation, and depyrogenation.
Key Responsibilities:
- Designing, executing, and reporting on PV/Process Performance Qualifications.
- Designing, executing, and reporting on validation studies for equipment, systems, and processes.
- Providing 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.
- Participation in external regulatory inspections and supporting Site Change Control process.
- Capable of troubleshooting validation issues associated with projects, process development etc.
Requirements:
- Degree in Science (Chemistry, Micro., or Pharmacy preferred) or Engineering Chemical/Mech/Elec.
- 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 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 an advantage.
Benefits:
- This is a 12-month contract opportunity.
Others:
- Our client is a pharmaceutical company based in Waterford.
