Regulatory Compliance Engineer
1 week ago
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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