*Hi Associate,*
This is Atul from TRG and we have requirement for the
Position *Business Analyst with FMS**. *I am sending the Job description to
you. If you interested than please reply me with your updated resume.
*Please Share Profile at-----------a...@tresourceinc.com
<http://sourceinfotech.com/>*
*Looking 9+ years with Must have FMS exp.*
*Position: Business Analyst with FMS*
*Location: Waco , TX*
*Duration: 9 Months*
*JOB DESCRIPTION Title:*
Position Description
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
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.
Thanks & Regards,
Atul Singh | Technical Recruiter
Technology Resource Group Inc.
1700 Park St, Unit 212, Naperville IL, 60563
Office: 408-709-1760 Ext : 9749
atul.ustrg *Y Mail*: atul.ustrg | Fax: 408-884-2409
a...@tresourceinc.com | www.tresourceinc.com
<https://www.linkedin.com/pub/atul-singh/53/503/220>
<https://www.linkedin.com/pub/atul-singh/53/503/220>
<https://www.linkedin.com/pub/atul-singh/53/503/220>
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