Full Description

Net2Source, Inc. is one of the fastest growing IT Consulting company across USA. N2S is headquartered at NJ, USA with its branch offices in Asia Pacific Region. N2S offers a wide gamut of consulting solutions customized to client needs including staffing, training and technology.

Responsible for

• Approve system life cycle deliverables (SDLC) and activities to ensure that regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is captured and reported to support validation activities.

• Represent IT Quality on cross-functional teams with IT R & D in support of SDLC activities.

• Consult on the authoring and conformance of validation-related deliverables and activities in regards to corporate SOPs and current regulations.

• Provide guidance, training and support to IT personnel in their validation efforts, to ensure compliance.

• Provide quality assurance oversight for system related issues (Test incidents, issues, etc.)

• Advise technical personnel and project teams on regulatory compliance and interpretation and recommend appropriate corrective actions where needed.

This job requires the IT Quality Analyst to attend department and user meetings, system assessment meetings, trainings, and other essential tasks. The IT Quality Analyst must maintain a professional manner in representing the company and in working with its agents and associates. The individual should demonstrate initiative and self-direction while also knowing when to seek assistance. This person must also be able to routinely schedule and complete multiple tasks and be timeline driven.

Requirements

• Bachelor's/Master's Degree

• 7+ years IT Quality / Validation experience in computerized system validation within a regulated environment preferably R & D application.

• Thorough knowledge of GxP and ERES (21CFR Part 11 and Annex 11) regulations and guidelines

• Detailed knowledge of the IT system development life cycle and software quality assurance in a regulated environment

• Thorough knowledge of IT Controls methodologies, including GAMP5 and ITIL

• Experience with risk analysis and risk management practices and tools

• Excellent communication skills, both verbal and written

• Knowledge of general software, database concepts and Data Integrity

• Knowledge of infrastructure technology and platforms

• The ability to work both independently and with teams

• Want to read more about Net2Source? , Visit us at www.net2source.com

Neetu Singh Senior Technical recruiter Net2Source Inc.

Desk: (201) 340 8700 Ext 576| D: (201) 297 1579|

Email: neetu.singh@net2source.com

Address: 317 George St. Suite 220, New Brunswick, NJ 08901

Website: www.net2source.com