Law

Title: Validation QA 

Duration: 6+ months

Location: Wilson, NC

Job Description:

The Validation Analyst develops and manages IT Validation/Qualification Documentation for computer systems in use to ensure regulatory compliance. This position is also expected to manage the development, review, and change control of computer system requirements and design documentation to ensure that critical systems are in compliance with FDA regulations as well as industry standards. This position will be responsible for management of Information Technology SOPs.

PRINCIPAL ACCOUNTABILITIES

Assuring FDA compliance: Working with Quality Assurance on FDA compliance information systems

Authoring of Documentation: Authoring validation requirements, design, testing, and SOP documentation.

         Write comprehensive Validation (test) plans including Traceability matrix.

         Create Test Protocols and detailed IQ, OQ, and PQ test scripts.

Management of Documentation: Index and storage of all FDA compliance documentation for the information systems

         Assemble completed test results and develop Validation Summary reports including completed Traceability Matrix and Testing Exception Reports.

Change Control: Manage change control on existing documentation to ensure it reflects current practices

BS/Equivalent Training/Certification and minimum of 6 years of relevant experience in computer systems validation and systems development life cycle methodologies.

In-depth knowledge of Computer Systems Validation and Systems Development Life Cycle Methodologies

Strong technical writing and skills

Technical Knowledge of computer systems and software –

MicroSoft software packages such as Outlook, Word, Excel, PowerPoint, Explorer, and MS Project

SAP, LIMS, or other Manufacturing and Distributions systems

DocCompliance or other Document Management System

Windows and Unix servers

Oracle DBMS

Citrix

Regards

Kevin

Amtex Systems Inc.

50 Broad Street, Suite 801

New York, NY-10004

Cell:  917-463-4086

GTalk: amtex.kevinb