● Audit the plant processes to ensure both internal and external regulations and standards are being adhered to.
● Ensure auditing and manufacturing documentation are kept up to date.
● Drive continuous improvement of core processes to ensure manufacturing quality is maintained while efficiency is optimized.
● Review of GMP documents to ensure company processes comply.
● Train and provide assistance to less experienced members of the QA team on quality procedures, protocols, and documentation.
● Train production staff on quality procedures, protocols, and documentation
● Maintain quality assurance documentation.
● Develop the standard measurements for processes to be compared against.
● Inspect and test processes and procedures – take measurements and compare to a predefined standard.
● Investigate measurements that are found to deviate from standards.
● Write Standard Operating Procedures (SOPs) for the manufacturing process.
● Coordinate investigation of quality issues with customers and suppliers.
● Review, approve and communicate root cause and corrective action to stakeholders.
Requirements
● Bachelor's or Master's degree in Chemical Engineering.
● Certificate in ISO 9001:2015- GMP.
● Previous experience in quality assurance.
● Working knowledge of tools, methods, and concepts of quality assurance.
● Solid knowledge of relevant regulatory standards.
● Good communication skills, both verbal and written.
● Excellent data collection and analysis skills.
● Strong attention to detail.