Compliance Specialist
Company: Eclaro
Location: New Brunswick
Posted on: May 9, 2022
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Job Description:
Compliance SpecialistJob Number: 22-03727 Be part of a company
that delivers life-changing healthcare solutions. Eclaro is looking
for a Compliance Specialist for our client in New Brunswick, NJ.
Eclaro's client is a leader in the Biopharmaceutical Industry,
providing quality, innovative, and affordable medicines that make a
difference in the lives of patients all over the world. If you're
up to the challenge, then take a chance at this rewarding
opportunity! Responsibilities: 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
Client 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; Good Manufacturing Practices (GMP), Good
Clinical Practices (GCP), Good Laboratory Practices (GLP), Good
Pharmacovigilance Practices (GVP), Food & Drug Administration
(FDA), and other regulatory requirements; FDA 21 CFR 11, EU GMP
Annex 11 and GAMP 5 standards; 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: Bachelors degree in a related
field from an accredited college or university, with a minimum of 5
years of related experience. If hired, you will enjoy the following
Eclaro Benefits: 401k Retirement Savings Plan administered by
Merrill Lynch Commuter Check Pretax Commuter Benefits Eligibility
to purchase Medical, Dental & Vision Insurance through Eclaro If
interested, you may contact:Jane
Bautistafroilyn.bautista@eclaro.com2012858622Jane Bautista -
LinkedIn Equal Opportunity Employer: Eclaro values diversity and
does not discriminate based on Race, Color, Religion, Sex, Sexual
Orientation, Gender Identity, National Origin, Age, Genetic
Information, Disability, Protected Veteran Status, or any other
legally protected group status.
Keywords: Eclaro, New Brunswick , Compliance Specialist, Other , New Brunswick, New Jersey
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