*Hi,        *

*

Good Morning! You are doing great. Kindly go through the below requirement
and let me know if you have any consultants available for this position.

Please mail the resumes to **[email protected]** **with current
location, visa status, availability & rate.            ***

* *

*Position: Lab Validation Analyst*

*Location: Chicago*

*Duration:  3 + months*

* *

*Position Overview:  ***

This position is responsible for leading and performing Lab Instrument
Validation.

Experience must include a technical understanding of QC lab instruments and
familiarity with working in a GLP environment, and QC/laboratory
instrumentation validation document writing/execution experience within
FDA-regulated environments.

Equipment may include, but are not limited to:



·        HPLCs

·        Mass Spectrometers/Spectrophotometers

·        Plate Readers

·        GCs, LCs,

·        Oscilloscope

·        Emulator Systems

·        Stability Chambers

·        Freezers & Refrigerators



*1.                  **Responsibilities*

·        Create & manage documents required for the development and
validation of the Lab instrument as per GLP and applicable FDA regulations.

·        Document included, but are not limited to

·        Authors Risk Assessment, Design Qualification (DQ), Design Review,
IQ Protocol/Report, OQ Protocol/Report, PQ Protocol/Report, Test Cases,
Trace Matrix, and Validation report.

·        Authors and/or reviews User Manuals, System Procedures & Standard
Operating Procedures.

*2.                  **Desired skills *

·        Minimum 5-8 years experience in Lab Instrument Validation in the
Life Science industry.

·        Experience in taking a risk based approach to validation

·        BS Chemistry , Chemical Engineering or relevant degree or
experience required

·        Excellent oral and written communication skills

* *

* *

*Thanks and Regards, ***

*KEERTHI***

*EZEN Computer Services Inc.,***

*609-945-1186***

*609 452 5613 (F)***

*[email protected]*

*www.ezencomp.com*

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