Job Role:
We are seeking a highly skilled Validation Specialist to lead our validation efforts. The successful candidate will have expertise in aseptic processing, lyophilisation, sterilisation, and depyrogenation.
* Develop, execute, and document Process Performance Qualifications (PPQs) and equipment, system, and process validations.
* Provide technical interpretation and guidance of current regulatory requirements for aseptic processing, lyophilisation, sterilisation, and depyrogenation.
* Ensure compliance with relevant quality management systems throughout the validation lifecycle.
* Participate in regulatory inspections and support change control processes.
* Analyse and troubleshoot validation issues associated with projects, process development, etc.
* Degree in Science (Chemistry, Microbiology, or Pharmacy preferred) or Engineering Chemical/Mech/Elec.
* Previous validation/product development experience is highly advantageous.
* Knowledge of Process Validation regulations, industry practices, and guidelines.
* Familiarity with GAMP, ISPE Baseline guides, AAMI/ANSI, PDA, and ISO guidelines.
* Strong understanding of quality and compliance regulations.
* Able to execute projects according to plan.
* Good knowledge of quality management systems.
* Excellent communication skills at organisational, team, and individual levels.