Catalent is looking to solve quality assurance issues in their manufacturing processes to ensure the quality of final products and adherence to regulatory guidelines.
Requirements
- Assess regulatory and quality risks in manufacturing activities and processes according to regulatory agency rules and guidelines
- Investigate and resolve quality issues and determine any deviations from established procedures
- Monitor and analyze quality data to identify trends and opportunities for improvement
- Maintain and update quality documentation and records
- Assist with protocol and implement validation procedures in accordance with Quality System Regulations (QSR), FDA and international guidelines
- Analyze and identify root causes for production and quality control issues and implement corrective actions
- Monitor all equipment used for manufacturing to assure quality of final products
Responsibilities
- Perform various quality assurance checks during all manufacturing processes
- Assess regulatory and quality risks in manufacturing activities and processes according to regulatory agency rules and guidelines
- Conduct quality audits of manufacturing processes and finished products
- Investigate and resolve quality issues and determine any deviations from established procedures
- Monitor and analyze quality data to identify trends and opportunities for improvement
- Maintain and update quality documentation and records
- Provide oversight of production activities including monitoring use of complex equipment
Other
- Requires a Bachelor’s degree in Drug Regulatory Affairs
- 4 years of experience in job offered or 4 years of experience in Related Occupation
- Full Time
- personal initiative
- dynamic pace
