1 New Message
Digest #2866
1
FW: Immediate Need!! Validation Specialist with a Major Pharma Compa by "David Pearlstein" dlpconsultingnj
Message
Tue Jun 25, 2013 8:28 am (PDT) . Posted by:
"David Pearlstein" dlpconsultingnj
Please contact the recruiter (below) directly if you are interested.
Good luck, David
-------- Begin forwarded message --------
Subject: Immediate Need!! Validation Specialist with a Major Pharma
Company
Date: 6/25/13 11:25:30 AM
From: "Ashley Lester"
To: dlpearls@optonline.
David
My name is Ashley Lester, Technical Recruiter with Diversant, LLC. I was
reviewing resumes in the job boards and came across yours. We have an
on-site contract opportunity with a Major Pharmaceutical Company in
Pennington, NJ for skills that may match yours. This is initially a 6
month contract opportunity with possible extension!
Based on the rate we receive from our client, the maximum rate we can
offer is $63/hr W2.
Below my name and address is a description provided to us from our
client. If you are interested in pursuing the opportunity please reply
to this email and let me know the best time to reach you by telephone.
***At our clients request, we are only able to submit W2 eligible
candidates. Sorry, no Corp to Corp.***
Ashley Lester
IT Recruiter
630 Freedom Business Center
3 rd Floor
King of Prussia, PA 19406
267-587-3655
alester@diversant.
<javascript:
www.diversant.
<https://console.
http://www.linkedin
<https://console.
This message is intended solely for the individual(s) to whom it is
addressed. If you are not the intended recipient, any dissemination or
copying is strictly prohibited. If you believe you received this message
in error, please notify the sender and delete from your system. Thank
you.
JOB DESCRIPTION:
¿ 6+ years experience
¿ Apply FDA, MHRA, and other applicable global regulations to the
development of computer systems supporting regulated business processes
¿ Follow SOPs and industry best practices
¿ Conduct training on good documentation and good testing
practices
¿ Facilitate the Computer system Validation Risk Assessment to
identify governing regulations and validation deliverables during the
development of the computer system
¿ Review validation deliverables for projects which are
contracted to third party suppliers
¿ Maintain close communication with stakeholders and team members
to keep apprised of computerized system needs, impacts on computer
validation, project validation status, and other relevant issues
¿ Assist in planning, implementing, and documenting user
acceptance testing
¿ Review computerized systems validation documents such as:
o Requirements Specification
o Design Specification
o CSV Risk Assessment
o Test Plans
o Test Summary Reports
o Data Migration Plan
o Pre/Post Executed Test Scripts
o Traceability Matrix
o Release to Production Statements
¿ Direct and review testing
¿ Provide guidance on quality issues that affect the integrity of
the data or the system
¿ Prepare validation summary and test summary reports
¿ Obtain and respond to QA review
¿ Participate in establishing standard quality and validation
practices
¿ Independently assess compliance practices and recommend
corrective actions
¿ Approve validated computer system related change requests
¿ Monitor regulatory and inspection trends and advise the
business on suitable action
¿ Advanced knowledge of complete MS Office suite and Visio. Firm
understanding of technology platforms as needed for project.
¿ Ability to create documents to an existing document standard.
¿ Working knowledge of Documentum.
¿ Excellent oral and written communication skills in English.
Strong expertise and ability to interview and accurately interpret
communication requirements of team members.
¿ Able to develop all documentation required for a 21/11
validated project, including Validation Plans and Summaries.
¿ Experience in producing software documentation and business
requirement documentation (minimum 3 yrs); experience with Software
Development Life Cycle Management and CFR 21 Part 11 compliance.
<https://console.
GROUP FOOTER MESSAGE
Put your Career Networking Group network to work ...
Join the CNG LinkedIn Group.
[Link is on the CNG Yahoo! Group home page.]
Join the CNG LinkedIn Group.
[Link is on the CNG Yahoo! Group home page.]
No comments:
Post a Comment