Quality Compliance Validation Lead ( QTS / TRACEWISE PROJECT )- job in Singapore

Keen Infotek, Inc have an urgent requirement as follows:
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Email: Thomas ***** **Thomas@keeninfotek.com* *****

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*REQUIREMENT DETAILS :-**
*
Quality Compliance Validation Lead ( QTS / TRACEWISE PROJECT )
Vernon Hills , IL
Duration : 8 Months+
Rate : open

*Purpose of the Position*:

1. Act as Validation Lead in the Quality Compliance organization for the
Quality Tracking System (QTS/Trackwise) project. The scope of this project
is the addition of two workflows—Audit and FCA—to the existing system.

*Critical Job Responsibilities*:

1. Generate / revise Validation Master Plans, Qualification Protocols,
Test Plans, Risk Assessments, Reports, as needed. May participate in
generating User Requirements, Functional and Design Specifications.
2. Gain understanding and follow defined Software Development Life Cycle
and company procedures. Ensure quality validation processes are executed as
defined by processes and procedures.
3. Participate in design meetings, as required, to gain knowledge of
project, system, customizations configuration to succeed at delivering
assigned project deliverables.
4. Communicate status, solutions and concerns. Disseminate information in
a timely manner within the team. Facilitate and address issues within
project.
5. Train testers on qualification process and incident reporting.
6. Manage validation schedule. Coordinate and assign testing to a team
of testers. Generate test scripts, as needed. Execute testing as
required.
7. Post-execution review of test cases for completeness, accuracy and
adherence to policies and procedures.
8. Assist in creation of and review/approval of Trace Matrix.
9. Overall document management for all validation deliverables including,
but not limited to: managing all aspects of validation package contents;
assisting in the routing/approval process of documents; archiving documents.
10. Collaborate with business, quality, and technical individuals
throughout project in generation of project / validation required
deliverables.

*Required Qualifications*:

1. Minimum BA / BS or relevant work experience in information systems,
engineering, science or business.
2. Highly skilled in Computerized System testing and validation in the
healthcare industry. Prefer at least 7 years validation experience in
application validation.
3. Knowledge of International GxP regulations (e.g. 21 CFR Part 11, 211,
820, PIC/s), as well as Sarbanes-Oxley, HIPAA, and privacy regulations.
4. Strong technical knowledge—experience with Trackwise application, a
plus.
5. Experience working in a highly regulated environment; GxP, QSR
framework preferred.
6. Solid project and organizational skills. Ability to multi-task. Must
have strong analytical problem solving skills.
7. Excellent communication including written, verbal, and listening
skills.
8. Self-motivated, detail oriented, takes initiative and ability to work
independently without close supervision.

.

*
**Thanks & Regards*

*Thomas Fedrick
**Recruiting Specialist "IT Services"*

*[image: cid:image001.jpg@01C90F77.7F01D080]*

*710 E || Ogden Ave || Suite #110 || Naperville || IL 60563 ||
Ph: 630-225-7137 || Fax: 630-206-0325
*Thomas@keeninfotek.com || www.keeninfotek.com
http://www.linkedin.com/in/thomasfedrick

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