The QA Engineer provides primary Quality Assurance review and approval for documents such as Product Development, Process Validation, Equipment Qualification, Computer Software Validation, Method Validation, deviations, and other cGMP documentation and studies conducted at facility.
- Supports the performance of quality risk assessments.
- Ensures that all information and documentation conform to company policy, cGMP’s and all other applicable FDA guidance’s.
- Develops and evaluates quality, system and process standards to ensure reliability and compliance with company standards and governmental and regulatory requirements.
- Support Equipment Validation activities for manufacturing equipment.
- Conducts CAPA and deviation investigations as required.
KNOWLEDGE, EXPERIENCE AND EDUCATION
- Bachelor’s degree in a scientific discipline or closely aligned field.
- Minimum of one or two (1-2) years of experience working in an FDA regulated industry, pharmaceutical experience, or similar industry is highly preferred.
- Demonstrated understanding of and ability to apply cGMPs and US FDA laws and requirements in an FDA regulated industry.
- Strong functional knowledge of SAP systems.
- Demonstrated ability to organize multiple tasks and change priorities to meet project deadlines