Description
Responsibilities:- Partner with R&D and Engineering teams to develop and transfer manufacturing processes to external contract manufacturing organizations. Ensure process development and transfer activities are based on sound quality engineering principles and in compliance with applicable regulations and standards.
- Develop and update process development and transfer documentation such as:
- Standard operating procedures, work instructions, and specifications
- QC test plans, acceptance criteria, and reports
- process and equipment validation plans, protocols, and reports
- Design change plans, requests, and reports
- Manufacturing process flowcharts
- Interface with cross-functional teams and external Contract Manufacturing Organizations to support routine product manufacturing. Ensure product manufacturing meet company quality expectations as well as applicable regulations and standards
- Work up to 50 percent of time at contract manufacturing facilities, supporting the following routine production and quality assurance activities:
- Identification and resolution of production and quality system deficiencies
- Review of GMP documents (batch records, forms, protocols, SOPs) to ensure manufacturing steps are appropriately documented, verified, and in compliance with GDP.
- Investigation / troubleshooting of equipment and process failures
- Participate in efforts related to making continuous improvements in product quality
- Tracking and review of production metrics
- Implementation of process improvement efforts
To find out more about Real please visit www.realstaffing.com