Global Computer Validation Specialist

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Global Computer Validation Specialist

• Marlborough, MA
• Contract

Company Description

Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job.

Job Description

Hands on position responsible for authoring test scripts and other

CSV documents required for the validation of GAMP 5 Category 4

(configurable off the shelf) computer systems. Candidates should be

familiar with COTS systems used for clinical development and quality

activities in a pharmaceutical environment. Work with business users

and Information Technology to ensure the systems remain in a validated

state through appropriate change control procedures. May require

participation in early morning and/or evening teleconferences with

global project teams.

1. Create

and/or review computer system validation test scripts, validation

schedules, risk assessments, requirement specifications, protocols and

reports, traceability matrices, and validation summary reports according

to the timelines in the project plan. Review applicable procedures and

system training manuals as applicable. Participate in project team

meeting. (85%)

1. Document

requirements for business requirements, system security, user roles,

workflows, data flows, GxP requirements and how these systems fit into

the larger IT infrastructure. (10%)

1. Work

with IT and User Groups to: (a) evaluate change control requests, (b)

assess regulatory risk associated with such requests and (c) determine

the corresponding validation requirements for such changes. (5%)

Qualifications

• 2 – 3 years experience writing CSV test scripts, protocols and summary reports in global environments

• Bachelors or Masters in Computer Science, Computer Information Systems, Information Technology or related discipline.

• Knowledge and skills (general and technical):

• Sufficiently

• knowledgeable of FDA/EU/MHLW Regulatory Requirements and industry best

practices for computerized system validation to complete tasks

• Experience working with global teams particularly with team members from Japan
• Understands lifecycle approach as well as risk based approach to validation
• Generally familiar with GXP regulations particularly in the GCP and Quality areas
• Able to work both independently and as a member of a cross-functional project team
• Good written and oral communication skills
• Good problem solving skills
• Microsoft products such as Word, Excel, Project, and Visio.
• Familiar

with Information Technology principles, functionalities and

capabilities of computer systems; and how computer systems relate to and

integrate with larger corporate IT infrastructures

Additional Information

$40/hr

6 MONTHS +

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Global Computer Validation Specialist

• Marlborough, MA
• Contract