Sr. Operations Quality Engineer

Par Health

Unknown
Cgmp manufacturing environment
Statistical process control and analysis
Quality system ownership and compliance
At Par Health, we believe great healthcare is built on getting the essentials right and prioritize quality and safety while fostering a culture of continuous improvement, accountability, and teamwork

Job Summary

  • At Par Health, we believe great healthcare is built on getting the essentials right and prioritize quality and safety while fostering a culture of continuous improvement, accountability, and teamwork.
  • The Sr. Quality Engineer leads quality system improvements, provides validation guidance, and supports regulatory compliance to ensure delivery of the highest quality product to customers.
  • This role involves cross-functional collaboration, statistical data analysis, supplier quality oversight, and participation in continuous improvement and risk management activities.

Matching Summary

At Par Health, we believe great healthcare is built on getting the essentials right and prioritize quality and safety while fostering a culture of continuous improvement, accountability, and teamwork.

Skills & Requirements

Must-have

  • cGMP manufacturing environment
  • Statistical process control and analysis
  • Quality system ownership and compliance
  • Supplier quality management
  • Root cause analysis and corrective actions
  • Validation activities SME
  • Regulatory filings and audit support

Nice-to-have

  • Six Sigma tools knowledge or certification
  • Project management and team building
  • Continuous improvement leadership
  • Effective communication and training skills
  • Risk analysis and process mapping
  • Lean manufacturing principles
  • Customer and supplier interaction

Key Requirements

  • B.S. degree in Engineering or Science
  • Minimum 5 years QA/pharmaceutical manufacturing experience
  • Knowledge of ICH Guidelines Q7, Q8, Q9, Q10
  • CQE or CQA certification preferred
  • Experience with FDA, EMA, USP, EP, JP regulations
  • English language proficiency

Work Rights

Not specified

Tailored Resume

Cover Letter