
Validation Specialist
11 hours ago
Job Title:
">- Validation Specialist
Overview
Our client is a leading pharmaceutical company seeking a Validation Specialist to join their team. As a key member of the validation team, you will be responsible for designing, executing, and reporting on process validation/Process Performance Qualifications (PVs) and equipment validation studies.
Responsibilities
- Designing and executing PVs and equipment validation studies in accordance with industry regulations and guidelines.
- Providing technical interpretation and guidance on current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation, and depyrogenation.
- Maintaining validation documentation throughout the validation lifecycle.
- Participating in external regulatory inspections and supporting site change control processes.
- Troubleshooting validation issues associated with projects, process development, etc.
Requirements
- Degree in Science or Engineering (Chemistry, Microbiology, or Pharmacy preferred).
- Previous validation/product development experience would be highly advantageous for this role.
- Knowledge of Process Validation regulations and industry practices.
- Understanding of relevant quality and compliance regulations.
- Able to execute projects to plan.
- Good knowledge of quality management systems.
- Effective communication skills at an organisational, team, and individual level.
What We Offer
- A challenging and rewarding role within a dynamic team.
- Opportunities for professional growth and development.
- Collaborative and supportive work environment.
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