Senior Validation Analyst

Employer
Worldwide Clinical Trials
Location
Nottingham, GB
Salary
Competitive
Closing date
11 Oct 2020

View more

Discipline
Manufacturing, Validation
Hours
Full Time
Contract Type
Permanent
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SUMMARY: To co-ordinate and perform validation and maintenance activities for Worldwide's GxP systems. To represent Worldwide's in sponsor audits and regulatory authority inspections.

RESPONSIBILITIES:
  • Oversee the validation status of Worldwide GxP systems
  • Develop validation strategies for new or modified systems
  • Author, review and approve computer system validation documentation
  • Catalogue and track project-specific validation documentation
  • Track and report on all technology-related compliance activities
  • Assist in training and mentoring Worldwide team members in the technical competencies of validation and the authoring of validation deliverables
  • To review existing approaches to Worldwide SDLCs with a view to improving procedures
  • Develop and implement QMDs associated with validation
  • Responsible for preparing materials for Worldwide audits
  • Assist on sponsor audits

OTHER SKILLS AND ABILITIES:
  • Ability to communicate concisely and effectively in both written and spoken English
  • Ability to create and deliver training materials
  • Proven stakeholder management skills
  • Strong Problem Solving and Relationship Management skills
  • Proficient in the use of common office software
  • Self-motivated individual who can positively contribute to a team environment
  • Ability to prioritize and handle multiple projects simultaneously
  • Flexible and able to use sound independent judgment and take initiative to assess information
  • Ability to demonstrate attention to detail
  • Able to make effective decisions in a fast-paced, highly dynamic environment

REQUIREMENTS:
  • Educated to degree level in a relevant discipline or able to demonstrate equivalent experience
  • At least 5 years' experience within a validation or compliance environment.
  • Experience of document authorship and control
  • Demonstrable experience of system validation processes
  • Demonstrable experience of working within organizations employing GAMP and GxP compliance
  • Contract Research Organization (CRO), Clinical or Medical experience
  • Understanding of clinical trials, blinding, patient safety, data integrity and associated regulations

Desirable but not required:

ISEB/ISTQB Foundation certificate in Software testing

#LI-KP1

Are You Seeking A Career With Purpose?

The time is right to join our growing team, consisting of 1,600 talented and dedicated employees from across the globe. We’re doing innovative and exceptional work each and every day. Our team is filled with purpose, as we support our sponsors in the discovery of cures and treatments for diseases affecting millions of people around the world.

If you’re looking to join an energetic and collaborative team that is valued and supported by company leadership, committed to operational excellence and open to creativity and innovation, Worldwide Clinical Trials could be the ideal place for you. We have exciting opportunities in clinical drug development, project management, corporate functions, sales, and more. Explore current openings and learn more about Worldwide’s culture below.

What We Believe

At Worldwide we operate under a shared mission, vision and set of cultural values. But these aren’t just words on a page. They are a daily inspiration and a shared commitment. Because we know that when we work towards a common goal and when we bring our best selves to the job every day we can climb mountains for our customers!

Contact Us
  • 2nd Floor
  • 172 Tottenham Court Road
  • W1T 7NS
  • GB
  • 0207 121 61 61
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