Computer Systems Validation Lead

Job type:
1-2 Weeks
8 months With possible extension
DG Business Solutions Inc
flag_no USA
project ID:

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Computer Systems Validation Lead - Life Sciences domain - GxP environment

* 10+ years' experience in Quality and Compliance with substantial hands-on computer system validation experience
* Prior experience leading/mentoring other validation professionals
* Experience in FDA regulated environment with good understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards and Risk based validation.
* Experience in reviewing system test and user acceptance test scripts, Traceability Matrix and Design Specs.
* Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/validation reports.
* Experience in Software Development Lifecycle (SDLC).
* Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
* Experience in Change Control.
* Experience on various FDA standards (21 CFR Part 11, 210, 211, 820)
* Experience is creation of SOPs.
* Knowledge of FDA guidance's and industry standards (ie, GAMP)
* Hands on experience in HP Quality Center and QTP.
* Strong verbal and written communication skills.
* Perform assessments of computer systems and processes at client sites (compliance with internal procedures, industry best practices, and regulatory requirements)
* Develop validation strategy documents, write user requirements, SOPs, IQ/OQ/PQ, and create validation summary reports
* Provide guidance and oversight of validation activities for projects involving GxP relevant computer systems
* Work closely with project team members to incorporate appropriate elements of quality and compliance into the system life cycle
* Provide management, guidance, and oversight of testing activities
* Review and approved computer system validation work products, assuring thoroughness of validation planning and making appropriate progress towards timely completion of validation deliverables
* Provide input to validation planning for IT Projects
* Provide tactical direction and guidance for changes to regulated computer systems
* May perform internal and external compliance audits
* Provide pre-sales, sales support and assist with new solution development as needed
* May mentor/lead other validation specialists

If you feel this requirement suits to your profile and interested please send in your updated Resume in Word format along with rate expected per hour and contact details to move forward. REPLY for A quick response, one of our team members would give you a call and take this to next level.