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Job Summary:
The
IT Compliance Specialist will
collaborate with Global IT Management,
Corporate Regulatory and associates, on
all compliance initiatives associated
with applicable FDA regulations and ISO
standards. He/She will need to work with
both Management and associates on
resolving compliance issues and
executing strategies for maintaining
compliance.
Job
Description:
The
IT Compliance Specialist will perform
all or some of the following Job
description:
-
Identify
areas of compliance risk and approaches
to address those risks (systems,
processes and practices)
-
Plan,
perform, and report the results of
internal compliance assessments and
audits against the existing Quality
System (e.g. 21 CFR Part 11 Assessments)
-
Conduct
compliance risk assessments of projects
and/or systems
-
Manage &
Track Corrective Actions to Audit
Observations
-
Develop &
Implement IT Policies & Procedures
-
Deliver
on-going Compliance Training & Education
to the organization
-
Manage /
Maintain relationships with Corporate
Regulatory partners.
Minimum Requirements / Knowledge / Skill
For IT Compliance Specialist Job
-
Working knowledge of SDLC is
critical
-
Working knowledge of testing
concepts, verification and
validation techniques, risk
management and measurement programs
-
Prior
experience preferred
-
Ability to perform systems audits
for compliance to SDLC methodology
and regulatory requirements
-
Ability to perform system's
validation in regulated industries
(i.e. pharmaceutical / device
manufacturers)
-
Ability to write, review and/or
approve SDLC validation deliverables
throughout all phases of a system
implementation
-
Ability to work in SAP as an end
user, developer, quality assurance,
or validation support
-
Previous experience with the
compliance risks and quality
controls for multiple modules of SAP
4.7 or ECC 6.0 is a strongly
desired, but not required
-
Experience in Supporting External
Inspections and Audits (e.g. FDA,ISO)
-
Practical Working Knowledge of FDA
QSR's, ISO 13485, FDA 21 CFR Part
11, FDA/ISO regulations relevant to
Computer and Software Systems
Validation
-
Ability to demonstrate practical
application of Part 11 requirements
into system design and associated
Design History File (DHF)
deliverables
-
Ability to develop creative
solutions that maintain compliance
to policies and procedures and still
meet project/user goals
-
Excellent communication skills
-
Ability
to
clearly convey subject matter
expertise to business end users and
IT associates
Ability to comfortably present
information to a large group as well
as create concise and informative
written communication
Ability to handle resistance from
end users, in a respectful and
non-combative manner
Ability to influence others is key
Ability to communicate issues or
potential risks to Compliance Team
swiftly and responsibly.
Understanding of responsible
communication is key
Ability to successfully partner with
a multitude of personality types
Experience in Project management.
Minimum Education Requirements /
Certification / Licensure For
IT Compliance Specialist Job
-
6-Sigma Trained / Certified is a
plus
-
ASQ certification is a plus.
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