Senior Project Manager

Sevagan

sevagan at krgtech.com

KRG Technologies Inc.

661 367 8000 * 513

10 -12 Yrs IT exp which includes 7-8 yrs in Pharma

· Developing RFP, review responses and selecting vendor.

·Facility monitoring system design.

·Driving all Risk Assessments, Functional Specifications and Validation efforts.

·Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.

·Project Management / Planning practices, principles, tools and techniques.

·Pharmaceutical industry practices and principles including environmental monitoring systems.

·Company policies and procedures, including personnel and safety rules and regulations.

·Experience in a pharmaceutical manufacturing environment preferred, including GMP, Facilities and Manufacturing equipment.

·Knowledge of cleanroom monitoring including but not limited to viable air sampling, total particulate sampling, viable surface sampling, pressure differential monitoring, and temperature & humidity monitoring.

·Knowledge of aseptic cleanroom environments.

Additional Information

Client - HCL America Inc

10 -12 Yrs IT exp which includes 7-8 yrs in Pharma

·CurrentGood Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.