Endogastricsolutions is seeking a Lead Operations Quality Engineer to oversee quality engineering activities, including investigations, corrective actions, and compliance in the pharmaceutical manufacturing environment. The ideal candidate will have extensive experience in quality assurance, strong statistical analysis skills, and the ability to lead continuous improvement initiatives
Job Summary
The Lead Operations Quality Engineer has overall responsibility for the investigations, corrective actions, change controls and compliance activities that occur in the Quality Engineering group.
The role provides input into regulatory filings as well as guidance for the various elements of the Quality System, including but not limited to Validation, Deviations, Risk Management, and CAPA.
At Par Health, we believe great healthcare is built on getting the essentials right and foster a culture of continuous improvement, accountability, and teamwork.
Matching Summary
Match Score: 85
Endogastricsolutions is seeking a Lead Operations Quality Engineer to oversee quality engineering activities, including investigations, corrective actions, and compliance in the pharmaceutical manufacturing environment. The ideal candidate will have extensive experience in quality assurance, strong statistical analysis skills, and the ability to lead continuous improvement initiatives.
Skills & Requirements
Must-have
Quality System ownership
investigations and corrective actions
change control management
regulatory compliance
statistical analysis
process improvement activities
Nice-to-have
continuous improvement culture
teamwork and accountability
passion for improving lives
elevating the essentials
Key Requirements
Bachelor’s degree in scientific or technical field
Minimum of 10 years’ experience in QA/pharmaceutical manufacturing
Knowledge of ICH Guidelines, FDA, EMA, USP, EP, and JP