IT Compliance and Validation Supervisor
Company: Renaissance LLC
Location: Lakewood
Posted on: January 13, 2021
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Job Description:
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.OverviewThe 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 Sr. Manager of Compliance 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 tasks. Responsibilities--- 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.Qualifications*
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
issues.PI127909817
Keywords: Renaissance LLC, Lakewood , IT Compliance and Validation Supervisor, Other , Lakewood, New Jersey
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