Par Health is seeking a Lead Operations Quality Engineer responsible for overseeing quality investigations, corrective actions, and compliance activities in the Quality Engineering group. The ideal candidate should have a strong background in quality assurance within a pharmaceutical manufacturing environment, with a focus on continuous improvement and regulatory compliance
Job Summary
The Lead Operations Quality Engineer is responsible for investigations, corrective actions, change controls, and compliance activities within the Quality Engineering group, providing direction to other Quality Engineers.
This role interprets and applies current regulations and guidance to ensure site policies and procedures provide a compliant framework for Quality Operations, interfacing with Process Engineers and Production Management.
Key responsibilities include providing input into regulatory filings, managing elements of the Quality System such as Validation, Deviations, Risk Management, and leading continuous improvement activities.
Matching Summary
Match Score: 85
Par Health is seeking a Lead Operations Quality Engineer responsible for overseeing quality investigations, corrective actions, and compliance activities in the Quality Engineering group. The ideal candidate should have a strong background in quality assurance within a pharmaceutical manufacturing environment, with a focus on continuous improvement and regulatory compliance.
Skills & Requirements
Must-have
Quality System Management
Regulatory Compliance
Root Cause Analysis
Corrective and Preventive Actions (CAPA)
Statistical Process Control (SPC)
Risk Management (FMEA)
Nice-to-have
Continuous Improvement Leadership
Cross-functional Team Collaboration
Supplier Quality Development
Data Trending and Analysis
Training and Mentoring
Key Requirements
Minimum 10 years' experience in QA/pharmaceutical manufacturing
Bachelor's degree in a scientific or technical field
Knowledge of ICH Guidelines, FDA, EMA, USP, EP, JP regulations