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SDLC SOP ITIL Accurev Management Specialist
(Jobs in DURHAM, NC)
 
Requirement id 49307
Job title Specialist
Job location in Durham, NC
Skills required SDLC, Life-Cycle Development, SOP, ITIL Accurev Management
Open Date 23-Oct-2015
Close Date
Job type Contract
Duration 12 Months
Compensation DOE
Status requirement ---
Job interview type ---
   Email Recruiter: coolsoft
Job Description Specialist: SDLC, Life-Cycle Development, SOP, ITIL Accurev Management

NOTE :
Start Date : 10/26/2015
End Date : 10/28/2016
Submission Deadline : 10/29/2015

Client Info : COMSYS

Description:
This is a long term PVL role in RTP. Please refer to Analyst Validation either standard or senior based on candidates experience.

As a member of the IT Quality & Regulatory Compliance team, the Lead IT Analyst Regulatory Compliance helps to define, plan, and perform duties that support major system development life cycle activities, including validation review and change control approval of IT systems.

II. PRINCIPAL DUTIES & RESPONSIBILITIES:

Approve system life cycle deliverables 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 & Regulatory Compliance on cross-functional teams in support of SDLC activities.
Consult on the authoring and conformance of validation-related deliverables and activities in regard 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 (deviations, incidents, etc.)
Assist in the development of IT Controls
Advise technical personnel and management on regulatory compliance and interpretation and recommend appropriate corrective actions where needed.

III. JOB DEMANDS:

This job requires the Quality Assurance and Validation Specialist to attend department and user meetings, system assessment meetings, trainings, and other essential tasks. The Quality Assurance and Validation Specialist must maintain a professional manner in representing the company and in working with its agents and associates. The Quality Assurance and Validation Specialist 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.

IV. JOB IMPACT:

The Quality Assurance and Validation Specialists role is essential in maintaining systems that are compliant with both regulatory (e.g., FDA) and corporate requirements and good business practices.

IV. QUALIFICATIONS:

A. Essential:
Thorough knowledge of GxP and ERES (21 CFR Part 11 and Annex 11) regulations and guidelines
Thorough knowledge of IT Controls methodologies, including GAMP5 and ITIL
Excellent communication skills, both verbal and written
Detailed knowledge of the IT system development life cycle and software quality assurance in a regulated environment
Knowledge of general software and database concepts
Experience with risk analysis and risk management practices and tools
Knowledge of infrastructure technology and platforms
The ability to work both independently and with teams at various levels in the organization
Excellent organizational skills and attention to detail and accuracy
Five or more years of experience in computerized system validation within a regulated environment
 
Call 502-379-4456 Ext 100 for more details. Please provide Requirement id: 49307 while calling.
 
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(Specialist: SDLC, Life-Cycle Development, SOP, ITIL Accurev Management in Durham, NC)
     
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