Hi Associate,
This is Atul from TRG and we have requirement for the
Position Senior Business Analyst. I am sending the Job description to you.
If you interested than please reply me with your updated resume.
Please Share Profile [email protected]
<http://sourceinfotech.com/>
*10 Yrs of exp which includes 7-8 yrs in Pharma*
*Position: ** Senior Business Analyst*
*Location: **Waco, Texas *
*Duration: 6 Months*
JD:
*Position Details*
Project Code/Excalibur ID
C153650
Requirement critical in scale of 1(high) to 3 (low)
High
Job Location/Client Location (with City & States)
Waco, Texas
No of openings/positions
1
Job Title/Role
Senior Business Analyst
Mandatory Skills
10 Yrs of exp which includes 7-8 yrs in Pharma
- 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
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.
Desired Skills
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.
Hiring Mode – (TP / FTE / CTH/Any)
TP
Preference on Work Authorization (USC/GC/H1/L2/OPT/Any)
Any
ITAR Clearance Required (yes /No)
Yes
Client Interview Needed for Selection (yes / No)
Yes
Interview Preference – (In-Person / Telephonic / Skype / Any)
Any
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
[email protected] | www.tresourceinc.com
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<https://www.linkedin.com/pub/atul-singh/53/503/220>
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