*PLEASE SHARE ME PROFILES ;;;;;;;;;;; jyoti.ve...@tresourceinc.com
*Contract position *
*10 Yrs of exp which includes 7-8 yrs in Pharma*
•Project management experience, including strong organizational and time
•Demonstrated and workable knowledge of cleanroom monitoring including but
not limited to viable air sampling, total particulate sampling, viable
surface sampling, pressure differential monitoring, and temperature &
•Demonstrated knowledge of aseptic cleanroom environments.
•Facility monitoring system design preferred.
•Experience of Risk Assessments, Functional Specifications and System
•Current Good Manufacturing Practices (cGMP), Food and Drug Administration
(FDA), and other regulatory requirements.
Experience in a pharmaceutical manufacturing environment preferred,
including GMP, Facilities and Manufacturing equipment
Support Allergan Waco’s Facility Monitoring System upgrade project by
providing Environmental Monitoring expertise in regards to cleanroom and
pharmaceutical manufacturing environments. Additionally, Business Analyst
will participate in the design, implementation, maintenance and support of
the new facility monitoring system.
*This position will be responsible for:*
•Being a contributing member of the Facility Monitoring System upgrade team.
•Gathering both technical and non-technical requirements, developing
business process analysis, user/systems requirement analysis and
•Participate in internal and external meetings relating to projects;
provides summaries of meeting to appropriate person(s) and makes
recommendations as appropriate.
•Support processes to meet 21CFR Part 11 and Annex 11 standards to
effectively manage information flow, data collection, and review activities.
•Create, modify, and manage Standard Operating Procedures (SOPs), Work
Instructions, and Risk Assessments, related to GMP systems.
•Lead validation effort to perform validation/qualification activities to
ensure data integrity and GMP system compliance.
Incumbent has full authority to make decisions and/or take action that is
required to carry out job duties.
*Thanks & Regards,*
*Technology Resource Group Inc. 3736 Hillsdale Court Santa Clara, CA 95051*
*Office* *:* *408-709-1760 Ex**t:750*
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