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intellectt
Nutley, NJ | Full Time
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intellectt
Nutley, NJ | Full Time
$100k-120k (estimate)
2 Months Ago
Software Validation Quality Consultant
intellectt Nutley, NJ
$85k-104k (estimate)
Full Time | Business Services 3 Months Ago
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intellectt is Hiring a Software Validation Quality Consultant Near Nutley, NJ

Role: Software Validation Quality ConsultantLocation: Nutley, NJDuration: 6 month project.Role OverviewWe are seeking a dedicated Software Validation Quality Consultant to collaborate with our Clinical Quality Assurance Systems Lead. This role is pivotal in executing internal validation projects and conducting vendor audits to ensure compliance and quality standards.
Key Responsibilities
  • Conduct comprehensive audits of computer systems and vendors to assess their Quality Management Systems, Software Development Life Cycle (SDLC), validation processes, and data integrity controls.
  • Review and verify Corrective and Preventive Actions (CAPAs) from system and vendor audits to ensure compliance and resolution effectiveness.
  • Approve internal validation efforts from a Quality Assurance (QA) perspective.
  • Serve as a liaison to business units, offering expert guidance and consultancy on software validation matters.
  • Provide support during health authority audits and inspections to ensure inspection readiness and compliance.
Qualifications
  • Bachelor’s degree in IT, Data Sciences, or related functional disciplines.
  • Solid understanding of software development processes, including Agile and Waterfall methodologies.
  • 3-5 years of experience in the pharmaceutical industry or a similar field.
  • 1-3 years of experience in Vendor/Computerized System Validation (CSV) auditing.
  • In-depth knowledge of regulations pertaining to software validation and development.
  • Familiarity with Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) is highly preferred.
  • Strong professional communication skills, excellent independent time management abilities, and capacity to handle multiple projects simultaneously.
  • Willingness to travel as required.
Position is based in Nutley, NJ, with a hybrid work model (2-3 days onsite).

Job Summary

JOB TYPE

Full Time

INDUSTRY

Business Services

SALARY

$85k-104k (estimate)

POST DATE

06/03/2024

EXPIRATION DATE

11/24/2024

WEBSITE

intellectt.com

HEADQUARTERS

ISELIN, NJ

SIZE

200 - 500

FOUNDED

2018

CEO

KIRAN MADALA

REVENUE

$5M - $10M

INDUSTRY

Business Services

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About intellectt

Intellectt Inc. was founded to set a new standard in Consulting and Staffing Industry. Our company is made up of dreamers, calculated risk-takers, diligent people that go to fight for the brand of our client. Intellectt Inc. and our affiliated brands provide innovative talent solutions that make our clients businesses better. Our verticals include Healthcare and IT. We exist to become the finest and most esteemed staffing company across the USA and we look forward to putting our talents to use to push your organization forward.

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