Currently we are looking for Business Analyst With Facility Monitoring System Experience for one of our client, kindly advice on your availability :
Job Title : Business Analyst With Facility Monitoring System Experience
Location : Waco , TX
Duration : Long Term
Position Description
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 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.
Education
Bachelor's degree in Microbiology or other related disciplines with Five (5) years' experience in use, management, and/or validation of electronic systems in a GMP environment.
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.
Dileep Pali | Sr. Recruiter |
Technology Resource Group Inc.
1700 Park St, Unit 212, Naperville IL, 60563
Office: 408-709-1760 Ext : 9957
G talk: palidileep |Yahoo id : palidileep
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