The incumbent will ensure compliance with Good Manufacturing Practice regulations for computerized systems used in manufacturing, packaging, and laboratories
Job Summary
The incumbent will ensure compliance with Good Manufacturing Practice regulations for computerized systems used in manufacturing, packaging, and laboratories.
This role involves providing independent quality approval for key validation documentation and managing the full lifecycle of computerized systems.
The position requires driving the resolution of regulatory non-conformances and supporting audit activities to maintain product safety and data integrity.
Matching Summary
Match Score: 85
The incumbent will ensure compliance with Good Manufacturing Practice regulations for computerized systems used in manufacturing, packaging, and laboratories.
Skills & Requirements
Must-have
GMP computerized system validation
21 CFR Part 11 compliance knowledge
5 years pharmaceutical industry experience
3 years validated lab systems experience
Regulatory inspection support
Nice-to-have
Continuous improvement culture
Stakeholder collaboration skills
Innovation in technology selection
Training program development
Key Requirements
Diploma or bachelor's degree in engineering
At least 5 years in regulated pharmaceutical manufacturing
At least 3 years in validated lab systems qualification