*Position: Business Analyst(Facility Monitoring System)* *Location: Waco , TX*
*Project Duration: 12+ Months* *Position Description* - 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 specifications. - 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. * Knowledge\Experience* - Project management experience, including strong organizational and time management skills. - 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 & humidity monitoring. - Demonstrated knowledge of aseptic cleanroom environments. - Facility monitoring system design preferred. - Experience of Risk Assessments, Functional Specifications and System Validation procedures. - 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. *Thanks & Regards,* *Md Faisal Zahid* Technical Recruiter Technology Resource Group Inc. 1700 Park St, Unit 212, Naperville IL, 60563 Office : 408-709-1760 Ext: 9865, Direct: 408-933-9532 *E mail id*: *[email protected]* <[email protected]> *Fax:* 408-884-2409 *www.tresourceinc.com* <http://www.tresourceinc.com/> [image: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: Description: linkedin] <http://www.linkedin.com/in/mdfaisalzahid> -- You received this message because you are subscribed to the Google Groups "Oracle Users" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at https://groups.google.com/group/oracle-users. For more options, visit https://groups.google.com/d/optout.
