Hi,

Please send the Candidate resume at [EMAIL PROTECTED]



Skill: Validation Engineers

Location: South San Francisco, CA* *

*Duration:* 12 plus months





Must be available to interview in person. Must have STRONG communication
skills.



*SKILLS ---*

-  At least five years of commercial validation experience in a GxP
environment OR minimum requirement is a Bachelors degree in a Life Science,
Computer Science, Engineering or a related discipline

-  A good understanding of the principles of software validation in a
regulated industry is required, to include, industry guidelines (PDA 18,
GAMP, ACDM), related FDA guidelines and regulations (Part 11, 312, 50 and
58), ICH GCPs.

-  Ability to work effectively with other members of a project team,
including programmers, validation specialists, and testers.

-  Excellent verbal and written communication skills a must.



*DUTIES ---*

-  Validation of PKDMS, WATSON LIM and other GLP Validation.

-  The candidate must have a sound understanding of the principles of
Computerized Information System (CIS) validation in regulated industries
(GAMP, Part 11, FDA guidelines and regulations).

-  Knowledge and experience with system/database design and architecture,
change control, as well as System Development Life Cycle (SDLC) and Quality
Assurance (QA) methodologies is required.

-  A good understanding of GLP and GCP regulations is necessary.

-  Experience with computer validation of GLP systems and GLP
instrumentation is a must.

-  The successful candidate will be responsible for maintaining change
control, developing validation strategies and providing guidance for
validation protocols (IQ/OP/PQ) used in development organization.





Thanks,

[EMAIL PROTECTED]
Technical Recruiter
RevisionTek
(A Pioneer in Information Technology Services)
http://www.revisiontek.com/

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