You will join our Regulatory Compliance Practice and partner with seasoned leaders, technical specialists, and subject matter experts to deliver the highest quality solutions to our clients with consistency and accuracy
Job Summary
You will join our Regulatory Compliance Practice and partner with seasoned leaders, technical specialists, and subject matter experts to deliver the highest quality solutions to our clients with consistency and accuracy.
Responsible for developing and executing a variety of validation and FDA compliance related documents/protocols for pharmaceutical equipment.
You will be surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader.
Matching Summary
You will join our Regulatory Compliance Practice and partner with seasoned leaders, technical specialists, and subject matter experts to deliver the highest quality solutions to our clients with consistency and accuracy.
Skills & Requirements
Must-have
Validation and FDA compliance documents
FAT, SAT, IQ and OQ documentation
QMS procedures, ICH Q1, CFR 21
Investigations and troubleshooting
Develop validation reports
Automated Systems validation
Nice-to-have
People-centric leadership
Entrepreneurial mindset
Mutual respect and integrity
World-class professional consultant
Key Requirements
Minimum 3 years project experience with validation
Minimum 3 years project experience in pharmaceutical/medical device