*Send me your resume to n...@e-zencomp.com*


Hi Partners,

Please find below requirement and kindly send me suitable profiles ASAP

* *

*Validation Engineers*

*Location: Menlo Park, CA
*

*Duration : 6 months+*



*Job Description:*



Skilled Validation Engineer to perform process and equipment validation
functions including protocol generation and execution, risk assessments and
validation impact assessments to maintain a high level of compliance with
GMP


*General Summary:*

Participates in the development, implementation and adherence to validation
test procedures (processes & equipment) ensuring product(s) meet appropriate
regulatory agency validation requirements, internal company standards and
current industry practices. This may include one or more of the following:

·        Prepares and reviews validation protocols and final reports (IQ, OQ
and PQ).

·        Develops and revises standard operating procedures (SOPs).

·        Assists with equipment selection and specification.

·        Coordinate the proper approval of plans and protocols.

·        Monitors validation change control and/or corrective actions.

·        Writes validation protocols and final reports (IQ, OQ and PQ).

·        Documents and reviews standard operating procedures (SOPs).

·        Coordinates the proper approval of plans and protocols.

·        Supports regulatory inspections or audits.

·        Tracks and coordinates validation change control and/or corrective
actions.


*Job Requirements:*

·        Bachelor’s degree in a scientific or engineering discipline or
equivalent.

·        Proficient in MS Office applications.

·        Experience with medical device based products and processing and
technologies

·        Experience with Cordis/Conor Medsystem

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