IT Compliance and Validation Supervisor
Company: Renaissance LLC
Posted on: September 4, 2020
Renaissance LLCAll qualified applicants will receive
consideration for employment without regard to race, color, sex,
sexual orientation, gender identity, religion, national origin,
disability, veteran status, age, marital status, pregnancy, genetic
information, or other legally protected status.Overview
The IT Compliance and Validation Supervisor is position is
responsible for leading a team that is tasked with supporting the
design, installation, implementation and validation of electronic
systems to meet all applicable industry standards and regulatory
requirements. The successful candidate will act as an advisor to
the Director of IT in all areas of system compliance and validation
and must have the ability to raise issues that they see as risk to
the company. This position frequently interacts with customers and
other groups at the Site and coordinates the IT validation
--- Guides the work efforts of direct reports, and mentors them in
all areas of compliance and validation.
--- Responsible for initiating/maintaining the IT Master Inventory
of Electronic Systems.
--- Prepare gap assessments, user requirements, functional and
configuration specifications, traceability matrix, test scripts,
validation plans, IQ, OQ, PQ and summary reports. Other validation
documentation as needed.
--- Gather, understand and document business objective.
--- Coordination of testing activities within the team, report
progress of testing and significance of unfavorable results.
--- Create, support and provide input into system administration
and standard operating procedures (SOPs) to ensure adequate
controls for maintaining the validated state.
--- Coordinate and execute the training of Subject Matter Experts
of electronic systems.
--- Make recommendations for improvements in laboratory
productivity and quality of data.
--- Initiate and implement change control activities in accordance
with current procedures
--- Work with IT leadership and business units to enhance existing
procedures to further the efficiencies of compliance execution.
--- Other tasks as assigned.
Bachelor's degree or Associates Degree in Computer Science,
Chemistry, Engineering or similar degree required, along with
related business experience and a proven record of achievement. A
minimum of 5 years of relevant experience in the pharmaceutical
industry is required, including at least 2 years' experience
supporting compliant IT systems. Must have a strong understanding
of 21 CFR Part 11 code. Must be able speak to all levels of the
organization regarding questions or concerns around compliance
Keywords: Renaissance LLC, Lakewood , IT Compliance and Validation Supervisor, Other , Lakewood, New Jersey
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