Computer system Validation (CSV) Specialist with Pharma Experience :: Marlborough, MA

 

Hi,      
Hope you are doing great!!      
Please go through the below job description and let me know your thoughts. 

Title: Computer system Validation (CSV):
Location: Marlborough, MA
Job Description

• 9+ years' experience as Computer system Validation, writing CSV test scripts, is REQUIRED.
• MUST have experience working on Datawarehouse / data lake or Data analytics validation projects.
• Experience with CTMS (Clinical Trial Management System) and GCP is REQUIRED.
• Experience in Computer Systems Validation environment with at least 2 years performing in the IT Quality and Compliance and/or data integrity roles.
• MUST have thorough understanding of IT Controls methodologies, including GAMP5 and ITIL.
• Perform and/or oversee CSV risk management activities; author/review risk assessments and perform risk mitigation activities as deemed appropriate.

Experience with GxP validated, 21 CRF Part 11 compliant computer systems is a MUST.
Measure and monitor CSV progress to senior management; generate reports and metrics as assigned.
Sufficiently knowledgeable of FDA/EU Regulatory Requirements and industry best practices for computerized system validation to complete tasks.
MUST havePharmaceutical, Bio-Technology, or Life Science industry experience.

Regards,
 
Shivam Dwivedi
Cybertec, Inc.,
11710 Plaza America Drive
Suite #2000, Reston, VA 20190
Direct: (732) 436-3439
Fax: 703-871-5291
Email: shivam@cy-tec.com
URL: www.cy-tec.com

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