PROGRAM MANAGER FOR VALIDATED SYSTEMS
REQUIREMENT #6239
RECRUITER: CINDI PISNOY
JOB LOCATION: PRINCETON
FEBRUARY 24, 2010
Project Description: Program Management experience a must. The Program Manger will be responsible for working with the various groups and stakeholders to coordinate schedules, timing of periodic reviews, managing the budget for the program and ensuring that the proper resources are committed to each individual project. The program manager will also be responsible for week to week tracking of overall progress to milestones, identifying and making the necessary adjustments to integrated project plans and issue/risk resolution and escalation to the appropriate individual or group.
Experience working in a Regulated Environment and System Validation a must.
Periodic reviews of validated systems must be performed to ensure that they remain in a validated state of control as required by numerous pharmaceutical regulations and client standards. At a minimum, a periodic review of validated computerized systems must be performed every three years from the initial system implementation date and high risk systems must be reviewed more frequently.
Funding has been set aside to create a Periodic Review Program. This will be a multi-year, multi-phase program consisting of numerous smaller projects to be completed between 2010 and 2012. The program will be organized based on risk so that riskier systems or those systems that were originally validated three or more years ago are reviewed first. The remaining systems will be prioritized and reviewed accordingly. A list of validated systems identified for periodic review organized by year and risk level will serve as the basis for the periodic review program schedule. The schedules for individual periodic review projects will be created and driven by the timelines of the overall project.
Required Skills: Program Management, Regulated Environment, System Validation
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Cindi: cp@alphaconsulting.
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Dear Recruiters:
Please see the attached new requirement(
Candidates must be your employees (no subcontracting please).
Resume(s) should be e-mailed directly to the recruiter and email address named in the requirement.
Sincerely,
Alpha Consulting Corp.
9 Auer Court, Suite E
East Brunswick, NJ 08816-6969
Phone: (732) 257-3003
Fax: (732) 613-9087
Visit us at http://www.alphacon
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