Computer System Validation (CSV) Specialist (Americas)

by | Career Opportunities

ADAMAS Consulting LLC
This is an immediate, full-time employment opportunity for an ambitious individual who is looking to serve as an industry expert, gain international experience and broaden their skills while being home based in the United States or Canada.

ADAMAS’s success is down to the caliber of its people – to reward them we offer a competitive salary with benefits, excellent working conditions and a fulfilling and rewarding career, with plenty of opportunities for further development.

ADAMAS Consulting LLC is an independent provider of GXP Quality Assurance services to the pharmaceutical, biotechnology and healthcare industries. ADAMAS Consulting LLC, established in 2007, is the fully owned US subsidiary of ADAMAS Consulting Group Ltd based in the UK.

 

Responsibilities:

  • Assist in Development, implementation, and maintenance of computerized system’s state of validation and compliance throughout its SDLC
  • Assist, Author/Review in Preparation of CSV deliverables such as Validation Plan, Test Plan, Summary Reports
  • Assist in supporting CSV and system process audits
  • Assist in supporting CSV and QMS internal audits
  • Assist in authorship, generation, and execution of validation documents (System Testing, IQ, OQ, PQ, UAT), for GxP regulated computerized systems
  • Review test scripts including IQ, System Testing and UAT scripts.
  • Perform Data Integrity, Supplier Qualification and FDA 21Part 11 assessments.
  • Assist in support computerized systems change management control and periodic review processes.
  • Exploring new opportunities to add value to organization and departmental processes
  • Helping others to accomplish results
  • Performing other duties as assigned

 

Requirements:

  • Attention to detail
  • Accountability in the workplace
  • A minimum of a bachelor’s degree in Science, Engineering or equivalent technical discipline is required
  • Preferred to have knowledge of validation of GxP computerized systems within FDA regulated environments with a strong understanding of industry standards and best practices for computer validation such as GAMP 5, 21 CFR Part 11, Annex 11, and applicable predicate regulations
  • Preferred to have Typing speed of 80+ wpm ​
  • Effective written and oral communication skills
  • Excellent time management, interpersonal and problem-solving skills.
  • Must demonstrate the ability to excel in a collaborative team-working environment.
  • Ability to Author SOPs and Work Instructions (WI) would be an advantage

 

Other Requirements:

  • Strong communication skills
  • Excellent writing skills
  • Positivity, flexibility, and adaptability
  • Highly professional and self-motivated
  • Ability to work independently in a home office setting
  • Confidence to work alone or in team
  • Up to 40% travel and ability to conduct remote audits

 

Benefits of Working at ADAMAS Consulting, LLC:

  • Competitive Salary
  • 20 Paid Vacation Days
  • Medical/Dental/Vision/Life Insurance Coverage
  • Flexible/Healthcare Spending
  • Working from home
  • Flexible working hours

 
If you like the prospect of a home-based role, flexible working conditions, excellent benefits and of course the opportunity to further your career within an exciting organization, then please submit your CV to Carly Davenport at carly.davenport@adamasconsulting.com.

No unsolicited calls from recruitment agencies please.

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