Click here to login or register
Reference # : 17-91435 Title : Validation Specialist III
Location : Westborough, MA
Experience Level : Start Date / End Date : 01/03/2018 / 04/06/2018  
Description
Job Title: Validation Specialist III (7632689)
Duration: 3 Months
Location: Bridgewater, NJ
Client: A Big Pharmaceutical Company

    
Duties:
  • To act in the change control process, supporting the validation as part of the system lifecycle after its goo live.  Experience with Vendor audits and ITS internal controls self-assessments is a strong differential .
  • Technical skills/ experience: It is very important to have Experience with Commercial operations solutions, such as CRM ( Customer relationship management ) and digital platforms (Mobile apps). Experience with CRM Veeva  and Patient support program platforms is a differential.
  • Regulations skills: GxP is a must, Knowledge on Data privacy, HIPPA and SOX are a strong differential . 
  • Year of experience: 5 years with a strong validation experience with Commercial operations Projects and applications ( CRM, for example) would be good enough.
  • The contractor will act as a team resource on projects or processes defined in the project description, in the following roles:
  • Provide validation support for multiple IS projects that require computer validation support. This work would be under the supervision of Client personnel. This may include the development and / or review of validation deliverables and
Activities such as:
  • Criticality Assessment
  • Validation Plan
  • User Requirements
  • Risk Analysis Report
  • Specification
  • Test Plans
  • Test Script(s)
  • Anomaly Report(s)
  • Test Reports
  • Authorization for Use
  • Validation Report
  • Change Management
  • Support usage of the IS Project Methodology
  • Will assist with defining validation strategy based on Client procedures
  • Assist with training on IS compliance topics (e.g. validation)
Skills:
  • Minimum 5 years experience with validation of IS computer systems in an FDA regulated environment.
  • Understanding of GxP regulations and computer validation principals Understanding of software development lifecycles Understanding of document management principals Demonstrated technical writing and oral communication skills.
  • Preferred:  Scientific education or experience, with test script design, technical document reviews, and strong interpersonal skills.
  • Experience with the HP Quality Center system is a plus
  • Preferred: Experience with Commercial Operations
  • Preferred: Experience with Website/Mobile Application/Digital
Education:
Bachelor degree: Computer Science (preferred) or Business/Sciences with computer science concentration. 

Required Skills:
  • Computer Validation
  • FDA
  • GXP
  • Risk Analysis
  • Software Development
Additional Skills:
  • Change Management
  • Document Management
  • Operations
  • Structured Software
  • Test Plans
  • Test Reports
  • Training
Thanks,
Ridhi Thapa
Pharma Recruiter
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: 973.295.4583 | Fax: 973.998.2599
Email: Ridhi.Thapa@artechinfo.com | Website: www.artechinfo.com
About Artech Information Systems LLC
Artech is an employer-of-choice for the last 25 years to over 7,500 consultants across the globe. We recruit top-notch talent for over 70 Fortune and Government clients coast-to-coast across the U.S., India, and China. We are #1 Largest Women-Owned IT Staffing Firm in the US and this may be your opportunity to join us! For more check: www.artechinfo.com

Connect with Artech through Social Media
Learn more about our company including the latest events at Artech, new job opportunities, jobseeker tips, and more. Follow us on Facebook, Twitter, LinkedIn, Google+, and YouTube