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From Home Computer System Validation Jobs in New York

ClifyX is seeking a Computer System Validation Tester to ensure compliance with industry standards in computerized systems validation. The role involves performing risk assessments, drafting ...

CSV Consultant

Raritan, NJ · On-site

$150 - $200/hr

We are seeking an experienced CSV Consultant with expertise in Computer System Validation (CSV ... Flexible work from home options available. #J-18808-Ljbffr

CSV Consultant

Raritan, NJ · On-site

$45 - $50/hr

We are seeking an experienced CSV Consultant with expertise in Computer System Validation (CSV ... Flexible work from home options available.

Validation Lead

Raritan, NJ · On-site

$50 - $55/hr

Strong Computer System Validation (CSV) expertise, especially within acquisition, divestiture, and ... Manage end-to-end processes from inventory and assessments to remediations and final dispositions.

... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

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Showing results 1-20

From Home Computer System Validation information

What is the difference between From Home Computer System Validation vs From Home Quality Assurance Specialist?

AspectFrom Home Computer System ValidationFrom Home Quality Assurance Specialist
CertificationsGxP validation, 21 CFR Part 11ISO 9001, QA certifications
Work EnvironmentPrimarily remote, focused on system testing and validationRemote or onsite, focused on process audits and compliance
Industry UsagePharmaceutical, biotech, healthcareManufacturing, software, healthcare
Job FocusEnsuring computer systems meet regulatory standardsEnsuring overall quality processes and compliance

From Home Computer System Validation primarily involves verifying that computer systems meet regulatory standards, especially in healthcare and biotech industries. In contrast, From Home Quality Assurance Specialist focuses on broader quality processes and compliance across various industries. Both roles may be remote and require similar certifications, but their core responsibilities differ in scope and focus.

What are the most commonly searched types of Computer System Validation jobs in New York?

The most popular types of Computer System Validation jobs in New York are:

What are popular job titles related to From Home Computer System Validation jobs in New York?

For From Home Computer System Validation jobs in New York, the most frequently searched job titles are:

What job categories do people searching From Home Computer System Validation jobs in New York look for?

The top searched job categories for From Home Computer System Validation jobs in New York are:

What cities in New York are hiring for From Home Computer System Validation jobs?

Cities in New York with the most From Home Computer System Validation job openings:

Computer system Validation Tester

ClifyX

Somerset, NJ • On-site

Full-time

Re-posted 16 days ago


Job description

Job Summary:
ClifyX is seeking a Computer System Validation Tester to ensure compliance with industry standards in computerized systems validation. The role involves performing risk assessments, drafting necessary documentation, and providing training related to validation processes.
Responsibilities:
• Ensure compliance to industry standards like GAMP5, FDA 21 CFR Part 11 on electronic records, electronic signatures etc.
• Define Risk based strategies for validation of computerized systems and author/review end-to-end Computerized Systems Validation documentation in accordance with Computerized Systems Validation Master Plan
• Perform system risk assessments, systems gap analysis, review and approve action plans to ensure compliance during and after the system validation
• Draft SOPs, writing scripts for IQ, OQ, PQ and handling CSV
• Help, guide and direct the project manager during the system implementation and validation process, and ensure compliance with corporate policies and procedures.
• Provide training related to computerized systems validation, quality and compliance to users and appropriate personnel
• Experience in Internal Audit, External Audit. Face regulatory, customer, IT Quality System related inspections for all computerized systems
• Responsible for review & verification of Corrective Action Plan for audits
• Perform periodic review/monitoring of computer systems implemented
• Proven experience in developing Master Validation Plan, validation scripts, Validation reports, all documentations required during CSV Implementation Process
Qualifications:
Required:
• Computer System Validation
• Life cycle
• Process Validation
• Risk Assessment
• FDA standards
• Test Planning
• Corrective Action Plan
• 8+ years of experience in CSV Implementation with MES/ SCADA experience
• Ensure compliance to industry standards like GAMP5, FDA 21 CFR Part 11 on electronic records, electronic signatures etc.
• Define Risk based strategies for validation of computerized systems and author/review end-to-end Computerized Systems Validation documentation in accordance with Computerized Systems Validation Master Plan
• Perform system risk assessments, systems gap analysis, review and approve action plans to ensure compliance during and after the system validation
• Draft SOPs, writing scripts for IQ, OQ, PQ and handling CSV
• Help, guide and direct the project manager during the system implementation and validation process, and ensure compliance with corporate policies and procedures.
• Provide training related to computerized systems validation, quality and compliance to users and appropriate personnel
• Experience in Internal Audit, External Audit. Face regulatory, customer, IT Quality System related inspections for all computerized systems
• Responsible for review & verification of Corrective Action Plan for audits
• Perform periodic review/monitoring of computer systems implemented
• Proven experience in developing Master Validation Plan, validation scripts, Validation reports, all documentations required during CSV Implementation Process
Preferred:
• Project Management skills and Team handling
Company:
ClifyX provides innovative business solutions which satisfy requirements for mission-critical reliability, scalability, interoperations. Founded in 1998, the company is headquartered in South Plainfield, USA, with a team of 501-1000 employees. The company is currently Late Stage.

ClifyX logo

About ClifyX

Sourced by ZipRecruiter

ClifyX is a well-established player in the IT Services sector that specializes in providing result-oriented technological solutions to a wide range of industrial verticals. Based in South Plainfield, New Jersey, ClifyX offers a comprehensive selection of IT services that include project staffing, application development, professional consulting, and other IT-based solutions. While the company's website, clifyx.com, does not divulge the exact founding date, it is clear that ClifyX has grown into a renowned name within their domain, thanks to their unwavering commitment to innovative practices. The company's mission statement revolves around harnessing the power of technology to assist their clientele in steering their respective businesses towards success.

Industry

Recruiting and staffing services

Company size

51 - 200 Employees

Headquarters location

South Plainfield, NJ, US

Year founded

1998