Sr. Validation Analyst at St. Louis, MO

Position:  Senior Validation Analyst Consultant

Location:   St. Louis, MO

Interview Mode; Phone and Skype

 

 

Requirements / Job Description:

A Drug Screen will be required prior to the start date.

 

 

Required Skills:

 

1)  Must have experience with writing, analyzing, executing, and approving FDA Validation documents.

 

2)  Experience writing and reviewing executed detailed software testing plans needed.

 

3)  Previous experience leading software implementation team on validation activities required.

 

4)  Knowledge of pharmaceutical laboratory testing preferred.

 

5)  10 + years' experience in quality role for software implementation projects needed.

 

Essential Functions of the Position:

 

. Analyze Laboratory Information Systems(LIMS) Business/User Requirement Specifications

. Analyze, Develop, and execute OQ/MQ and, if necessary, PQ plans and test cases

. Execute OQ/MQ/PQ plans and test cases

. Track validation activities and test results

. Prepare detailed reports and design documents based on results

. Resolve minor testing problems

. Identify deviations and provide recommendations for resolution

. Confer with management to determine LIMS system validation limits and objectives

. Create, populate, and maintain database for tracking validation activities and test results 

. Assist with MQ design and testing methodology such as AQC sampling or other analytical methodologies

. Resolve more complex testing problems

 

Warm Regards,

Samir Mondal

Executive Talent Acquition

 

T: 248.565.4747 *130

Fax: 248.254.7211

 

Email/ Gtalk: : smondal@tekshapers.com

http://www.tekshapers.com

 

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