Job Role: Validation Specialist
Location: Ireland
Overview:
A skilled Validation Specialist is required to work with a pharmaceutical client based in Waterford. If you have experience in aseptic processing, lyophilisation, sterilisation and depyrogenation, this could be the perfect opportunity for you.
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 processes.
* Capable of troubleshooting validation issues associated with projects, process development, etc.
Requirements:
* Degree in Science (Chemistry, Microbiology or Pharmacy preferred) or Engineering Chemical/Mechanical/Electrical.
* 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 with 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 (an advantage).