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Regulatory Compliance Expert

2 months ago

Somerset, New Jersey, United States System One Holdings, LLC Full time
Job Summary

We are seeking a highly skilled Validation Specialist to join our team at System One Holdings, LLC. As a key member of our Quality Assurance department, you will be responsible for ensuring the accuracy and reliability of our manufacturing processes.

Key Responsibilities
  • Develop and Implement Validation Protocols
    • Design and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment and processes.
  • Conduct Risk Assessments
    • Identify and prioritize validation activities across manufacturing sites to minimize risk and ensure compliance.
  • Ensure Regulatory Compliance
    • Stay up-to-date with industry regulations and standards, including FDA requirements for dietary supplements and OTC products.
  • Collaborate with Cross-Functional Teams
    • Work closely with Quality Assurance, Production, and Engineering teams to support validation activities and ensure seamless execution.
Requirements
  • Bachelor's Degree in Engineering, Chemistry, or a Related Field
  • Minimum of 3-5 Years of Experience in Validation within a Manufacturing Environment
  • Strong Understanding of Regulatory Requirements and Validation Processes
  • Proficiency in Statistical Analysis Software and Data Interpretation
  • Excellent Problem-Solving and Communication Skills
  • Experience with Computer System Validation and Knowledge of GAMP 5
  • Familiarity with Process Validation in a Highly Regulated Industry