
Pharmaceutical Validation Expert
1 week ago
Our organization is seeking a highly skilled and detail-oriented engineer to oversee the quality and compliance of our pharmaceutical products. As a key member of our manufacturing operations, you will play a vital role in ensuring adherence to regulatory requirements.
The successful candidate will be responsible for designing, executing, and reporting on Process Performance Qualifications (PPQs), conducting validation studies for equipment, systems, and processes, and maintaining validation documentation throughout the lifecycle.
You will work closely with cross-functional teams to ensure all validation activities comply with relevant standards, cGMP, and regulatory requirements. Additionally, you will provide technical interpretation and guidance on FDA and EU validation requirements for aseptic processing, sterilisation, depyrogenation, and lyophilisation.
To be successful in this role, you will require strong technical knowledge of pharmaceutical plants, validation, and process development. A degree in Science (Chemistry, Microbiology, Pharmacy) or Engineering (Chemical, Mechanical, Electrical) and 3-5 years' experience in a healthcare manufacturing environment (pharmaceutical experience preferred) are essential.
Required Skills and Qualifications- Design, execute, and report on PPQs
- Conduct validation studies for equipment, systems, and processes
- Maintain validation documentation throughout the lifecycle
- Ensure all validation activities comply with relevant standards, cGMP, and regulatory requirements
This is an excellent opportunity to develop your skills and experience in a dynamic and growing organization. You will have the chance to work with a talented team and contribute to the success of our company.
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