Regulatory Compliance Engineer

1 week ago


Sligo, Sligo, Ireland Gertek Project Management Full time

Gertek Project Management is a dynamic organization that values quality and excellence in all aspects of our operations. We are committed to delivering top-notch services to our clients, and we need talented professionals like you to help us achieve our goals.

We are looking for a Regulatory Compliance Engineer who will be responsible for ensuring that our equipment meets the highest standards of quality and reliability within a GMP-regulated pharmaceutical manufacturing environment.

The ideal candidate will have a solid understanding of GMP regulations and industry standards, as well as excellent documentation and communication skills.

Key Responsibilities:

  • Develop and execute validation protocols (IQ, OQ, PQ) to ensure compliance with GMP regulations
  • Generate and maintain accurate validation documentation to support regulatory submissions
  • Perform risk assessments related to equipment validation to identify potential issues
  • Coordinate with cross-functional teams (QA, manufacturing, engineering) to ensure seamless execution of validation activities
  • Ensure compliance with GMP and relevant regulatory guidelines throughout the validation process

Requirements:

  • Bachelor's degree in Engineering or a related science field
  • Experience in equipment qualification and validation in a GMP environment
  • Strong understanding of GMP regulations and industry standards
  • Excellent documentation and communication skills


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