Lead Validation Consultant

  • Fort Washington, PA
  • Contract

Company Description

Patel Consultants

1525 Morris Ave.

UNION, NJ 07083

 

Job Description

Company: Leading Pharmaceutical

Location:    Fort Washington, PA

Start Date:  Mid to Late November

Contract End Date5 to 6 months/ possible extension

Job Type:  W2 Contract only

Job Title:  Lead IT Quality Validation Consultant

 Pre-requisites

Healthcare experience, Safety experience preferred

 

-  Strong CSV skills - validation strategy development and validation documentation authoring

 

-  Independent worker that can hit the ground running

 

Job Description

Experience in Developing Validation Plan and Summary Reports Functional and Design
Documents and other project documents used to Computer Systems Validation Processes
Develop test plan and designs based on Business and System

Job Functions

 Organize, coordinate and gather requirements to perform integration/regression tests
Formulate and compose user training materials, procedure manuals for implemented systems
Conducting vendor audits and preparing audit reports
Performing assessment activities to formulate validation plans and 21 CFR Part 11 compliance plans

Executing validation plans and performing project management activities
Developing and writing SOP’s
Developing test scripts and user acceptance tests and executing test scripts
Performing IQ/OQ activities
Preparing all validation / 21 CFR Part 11 reports, documents, and deliverables
Conducting validation and 21 CFR Part 11 training
Contributing to the development of validation methodology and 21 CFR Part 11 compliance strategies

Qualifications

Requirements:


University Degree
5+ years Big Pharmaceutical or CRO industry experience with clinical/safety systems |
5+ years’ experience developing and implementing the validation process and validation deliverables |
Excellent understanding and experience with industry regulations, standards, and guidelines, e.g., ICH, GCP, validation, 21 CFR Part 11, etc.
Excellent interpersonal, communication, organizational, and project  management skills
Excellent presentation and writing skills
Knowledge of  Clinical Laboratory Application  
Understanding of Pharmacovigilance Systems, Terminologies and Process
Previous Experience supporting Validation project with cGxP Systems

If you are not interested, but know someone else who might be interested in this position please forward this resume to your friend.

Patel Consultants has been in Business since 1973. To get more information on Patel Consultants please view our website at http://www.patelcorp.com.

Additional Information

If you are interested, please e-mail me your resume in word document so that we can discuss further details and submit you to the client immediately.  Also, please provide the following information:

Availability:

Home address:

Citizen Status:

Desired Hourly Rate:

Reason for leaving current or last position:

Explain any Gaps in your resume if any:

Citizen Status:

 

If you are not interested, but know someone else who might be interested in this position please forward this resume to your friend.

 

Patel Consultants has been in Business since 1973. To get more information on Patel Consultants please view our website at http://www.patelcorp.com.


 

Thanks,

 

Mark Oppenheim

SR Technical Recruiter

Mark@Patelcorp.com

Patel Consultants

1525 Morris Avenue

Union, NJ 07083

http://www.patelcorp.com/

http://www.linkedin.com/in/oppenheimmark