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Validation and Quality Assurance Professional
hace 2 semanas
Job Summary:
The Validation Specialist is responsible for the qualification, validation, and ongoing compliance of manufacturing equipment within the Dry Line and Wet Line Platforms. This includes overseeing validation protocols, conducting testing, troubleshooting equipment issues, and ensuring adherence to industry regulations such as cGMP, FDA, ISO, and company quality standards.
Key Responsibilities:
- Develop and execute IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols for the following equipment:
- Dry Line Platform: Injection Molding Machine, Temperature Control Unit, Filling & Close, Oven, Depetaler.
- Wet Line Platform: Delenser Machine, Extraction and Hydration Machine, HH Machine Module 3, HH Machine Module 4.
- Perform Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
- Ensure that all validation activities comply with cGMP (Current Good Manufacturing Practices) and regulatory requirements.
Requirements:
- Bachelor's degree in Engineering, Life Sciences, or a related field.
- 3+ years of experience in validation, equipment qualification, or quality assurance within the pharmaceutical, biotech, or manufacturing industry.
- Strong knowledge of cGMP, FDA, ISO 13485, and GAMP 5 guidelines.
- Experience with thermal validation, process validation, and equipment calibration.
- Proficiency in data analysis, validation software, and technical writing.
- Strong problem-solving, organizational, and communication skills.
