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15 days old

COMPUTER VALIDATION SPECIALIST

Kelly Services
New Brunswick, NJ 08901
**BH: 3734114**


***** MUST BE ABLE TO WORK ON A W/2 HOURLY BASIS** **_(without Sponsorship)_** ******* **_NO C2C_** ***** REMOTE & ON SITE BLEND *****


**Our Client is expanding and currently seeks a**


**COMPUTER VALIDATION COMPLIANCE SPECIALIST**


**For a 6+month assignment with possible extensions!!**


**LOCATION: New Brunswick, New Jersey**


**Position is currently remote, but must report to an office once safe to do so.**


**Leverage your VALIDATION & VEEVA skills**


**to help take your career with our Client to**


**the "Next Level" for 2022 and beyond!**


**Overview:**


Our Client is seeking a Computer Validation Compliance Specialist to become part their Compliance department. You will 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.


**Responsibilities:**


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.


**Requirements:**


Experience in the BioTech/Pharmaceutical industry or similar regulated industry required.


Experience and knowledge of Veeva system capabilities **mandatory.**

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:**


4 year degree **mandatory.**


**Important information:**


+ **There is no per diem with this position**

+ **There is no relocation budgeted for this position. If this position requires you to relocate you will be responsible for those costs.**

+ **MUST be able to work without sponsorship or VISA transfer for this position.**


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


By partnering with Kelly Technology, youll have direct connections to top companies around the globegiving you the chance to put your tech skills to work on some of todays most intriguing, innovative, and high-visibility projects. In a world where change is the only constant, our unparalleled connections and IT market expertise help you take your skills exactly where you want to go. Were here to help you gain experience, keep learning, and move your career forward.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2021-11-12 Expires: 2021-12-13

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COMPUTER VALIDATION SPECIALIST

Kelly Services
New Brunswick, NJ 08901

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