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Validation Specialist
2 weeks ago
Job Opportunity:
About the RoleWe are seeking an accomplished professional to lead our validation efforts and ensure ongoing compliance of equipment, systems, and processes.
Main Responsibilities:
- Developing, executing, and reporting on qualification protocols for process performance and equipment validation.
- Collaborating with cross-functional teams to design and execute validation studies for various projects.
- Maintaining validation documentation throughout the product lifecycle while ensuring adherence to relevant standards and regulations.
- Providing expert guidance on regulatory requirements for aseptic processing, lyophilisation, sterilisation, and depyrogenation.
- Supporting site change control processes and participating in external regulatory inspections.
Requirements:
- Bachelor's degree in Science (Chemistry, Microbiology, or Pharmacy) or Engineering (Chemical, Mechanical, or Electrical).
- A minimum of 3-5 years of experience working in a healthcare manufacturing environment, preferably in the pharmaceutical sector.
- Proven ability to troubleshoot complex validation issues associated with projects and process development.
- Excellent knowledge of pharmaceutical plant operations.
- Prior experience in validation/product development would be highly beneficial for this role.
