Job Overview
A Certification in Validation ensures that processes, systems and equipment meet regulatory requirements and industry standards. The ideal candidate will have experience in aseptic processing, lyophilisation, sterilisation and depyrogenation.
* Developing and implementing validation strategies to ensure compliance with current regulations and guidelines.
* Maintaining validation documentation through the lifecycle of products and processes.
* Providing technical interpretation and guidance on current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation and depyrogenation.
* Supporting site change control process and participation in external regulatory inspections.
Requirements
* Degree in Science (Chemistry, Microbiology or Pharmacy preferred) or Engineering Chemical/Mech/Elec.
* Previous validation/product development experience would be highly advantageous for the role.
* Familiarity with Process Validation regulations and technical transfer industry practices.
* Knowledge of GAMP, ISPE Baseline guides and steam/dry heat validation publications such as AAMI/ANSI, PDA and ISO guidelines.
* Full understanding of quality and compliance regulations.
* Ability to execute projects to plan.
* Good knowledge of quality management systems.
* Good communication skills at organisation, team and individual levels.