Senior Project Manager

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.

Client - HCL America Inc

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

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