Manager, Validation Computer Systems
Company: Renaissance LLC
Location: Lakewood
Posted on: August 4, 2022
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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.OverviewThis
position is responsible for 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
MS&T 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 Computer System
Validation tasks.Responsibilities--- Guides the work efforts of
consultants and other team members, and mentors them in all areas
of computer system compliance and validation.--- Responsible for
providing input for maintaining the IT Master Inventory of
Electronic Systems.--- Provides leadership for GXP computerized
systems and applies risk-based methodology to
validation/qualification efforts in compliance with 21 CFR Part 11,
EU Annex 11, and GAMP 5.--- Manage continuous improvement efforts
for the CSV program, including guidance for impact as new or
revised industry regulations emerge.--- Oversee the overall
readiness of the CSV and Data Integrity programs to ensure programs
are compliant and ready for regulatory inspections.--- Review and
approve software validation strategy in support of custom software
systems, COTS configuration, workflow, and/or analytics to assure
compliance, overall accuracy, efficiency, and effectiveness of the
electronic computerized system.--- Assess systems for data
integrity and compliance with regulatory expectations including
assessment of third-party IT service suppliers and applications.---
Effectively identify and resolve complex system for compliance
issues and appropriately communicates gating items to management
and stakeholders.--- Review/assess proposed validated system
changes via CAPA, Change Control and Work Orders to identify
requirements necessary to maintain validated status.--- Participate
and support the external audit program for vendors related to GXP
computerized 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.---
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. --- Initiate and implement change
control activities in accordance with current procedures. ---
Participate in internal, client and regulatory agency audits as
Subject Matter Expert. QualificationsBachelor's degree in Computer
Science, Information Systems, 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. Experience with following types of
computerized systems is a plus: ERP, LIMS, Quality management
System (QMS), QC laboratory software and instrumentation. Strong
working knowledge in validation methodology (including GAMP) and
software development life cycle (SDLC) principles.PI187356957
Keywords: Renaissance LLC, Lakewood , Manager, Validation Computer Systems, Executive , Lakewood, New Jersey
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