IT Quality Compliance Specialist/Analyst-Pharma
Company: Orion Innovation
Location: New Brunswick
Posted on: June 22, 2022
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Job Description:
IT Quality Compliance Specialist/AnalystSkills: ValidationJob
Description --- Manage and coordinate activities associated with
the GxP IT Quality Assurance (QA) program for GPS and R&D
computerized systems regulatory compliance across the end-to-end
product lifecycle (GPS and R&D) for software development and
validation lifecycle activities associated with regulated
computerized systems to ensure conformance to cGxPs, guidance
documents, applicable industry accepted standards and
requirements.Carries out functions of the GxP-ITQA as directed
including but not limited to:Review and approval of key computer
system Validation Life Cycle (VLC) deliverables;Review and approval
of test scripts and defects associated with computer system
validation;Oversight of key Software Development Life Cycle (SDLC)
process such as incident, problem, change, release, etc.;Ensure
adequate and timely regulatory compliance support. --- Partner with
IT Validation to ensure risk assessments, incident management and
oversight are aligned to corporate and data protection standards.
--- Provide backup support for the department as needed and perform
other assignments as required. --- Support internal and external
(regulatory) inspection activities related to validated systems.
--- Provide support to assigned Quality programs, such as Data
Integrity Governance, Investigations, Global Quality Headquarters
Training and other, as assigned. --- Ability to manage multiple
projects, create and work within internal timeliness, solve
problems, deliver on commitments, and utilize interpersonal skills
in a cross-functional team. --- Operate effectively and with
minimal supervision, within a team or independently, performing
special projects and related duties, as assigned.Qualifications:
--- Experience in the BioTech/Pharmaceutical industry or similar
regulated industry required; --- Good understanding of the drug and
device development process from discovery through to regulatory
filing and approval of drug applications as well as commercial
manufacturing processes;o Good Manufacturing Practices (GMP), Good
Clinical Practices (GCP), Good Laboratory Practices (GLP), Good
Pharmacovigilance Practices (GVP), Food & Drug Administration
(FDA), and other regulatory requirements;o FDA 21 CFR 11, EU GMP
Annex 11 and GAMP 5 standards;o Data Integrity Guidance; ---
In-depth understanding of industry-accepted software development
and validation life cycle programs and related IT controls; ---
Experience with relevant GxP systems such as quality management
systems, document management systems, ERP, training/learning
management systems, clinical and laboratory systems preferred; ---
Understanding of quality risk-management concepts (ICH Q9)
preferred; --- Understanding of ITIL Framework concepts (e.g.,
Incident, Problem, Change management processes) --- Understanding
of Good Documentation Practices --- Project management practices
and techniques; --- Experience with automated testing practices and
tools preferred; --- Computer hardware, software including MS
Office and MS Project; --- External and internal inspections
support a plus; --- Excellent analytical, interpersonal, and
communication skills, including written and verbal
communication.Education & Experience:Bachelor's degree in a related
field from an accredited college or university, with a minimum of 5
years of related experience.Duration open endedPlease submit resume
to : career.americas@orioninc.comID: #REQ146132"We are an equal
opportunity employer and all qualified applicants will receive
consideration for employment without regard to race, color, creed,
religion, sex, sexual orientation, gender identity or expression,
pregnancy, age, national origin, citizenship status, disability
status, marital status, genetic information, protected veteran
status, or any other characteristic protected by law."
Keywords: Orion Innovation, New Brunswick , IT Quality Compliance Specialist/Analyst-Pharma, Professions , New Brunswick, New Jersey
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