Job Details

ID #12159224
State New Jersey
City Somerset
Job type Permanent
Salary USD Depends on Experience Depends on Experience
Source GalaxE.Solutions
Showed 2021-04-12
Date 2021-04-02
Deadline 2021-06-01
Category Et cetera
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Senior Validation Consultant

New Jersey, Somerset, 08873 Somerset USA

Vacancy expired!

What You Will Do

  • Provide validation support for computerized systems, software, and IT infrastructure that have been newly installed, upgraded, replaced and / or modified within the client organization.
  • Work on software validation and qualification based on client policies and procedures and external regulations and policies.
  • Be responsible for ensuring GxP computerized systems (includes hardware and software), are validated and controlled in compliance with industry guidelines.
  • Perform computer systems validation activities as they pertain to SDLC, including project planning, developing validation strategies, document development and document reviews
  • Author Standard Operating Procedures (SOPs), Work instructions, Guidelines and templates in the context of Software Development Life Cycle (SDLC) and computer systems validation/assurance
  • Ensure adherence to national and international regulatory guidelines on Electronic Records and Electronic Signatures and Data Integrity, cGMP, FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA and GAMP5 guidelines
Skills and Experience You Will NeedRequired:
  • 10-15+ years of Computer System Validation experience
  • Experience with cGxP, 21 CFR Part 11, GAMP and other compliance regulations and procedures
  • Experience investigating and troubleshooting automation and control systems (root cause analysis)
  • Ability to work in cross-functional team environments as well as independently
  • Strong written and verbal communication skills
  • Experience with attending external audits from agencies such as FDA, MHRA, etc will be a plus
Who We Are

GalaxE.Solutions For 30+ years, GalaxE has pioneered the use of data-driven automation tools to achieve business transformation and mission-critical change for some of the largest companies in the world. Using our proprietary solution set, GxFource®, we apply machine learning techniques and predictive analytics tools as part of a broad artificial intelligence strategy that provides effective impact and data-driven business transformation. Our services include everything from application modernization strategy and quality assurance, to platform consolidation, technology debt assessment, reverse engineering for systems and more. At GalaxE we value people and are committed to diversity and inclusion where our employees are made to feel comfortable and are encouraged to be authentic. We focus on cultivating both traditional IT and non-traditional “new collar” workers through our Outsource to America™ program. We are always looking for passionate, entrepreneurial-minded innovators and disrupters; game-changers that take ownership of the work they produce and bring it each and every day. Working with like-minded team members you will get a chance to discover, develop, and use cutting-edge technologies to transform the way we deliver creative business solutions. Sound like you? Join us and find out for yourself what it means for you, and your career, to be part of the GalaxE team. Let’s build something, together. #WeAreGalaxE, #CoolAutomation Equal Opportunity Employer/Veterans/Disabled

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