Opening for Business Analyst(Facility Monitoring System); Waco , TX

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: faisal@tresourceinc.com

Fax: 408-884-2409

www.tresourceinc.com

 

 

 

 

 

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