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Senior Validation Analyst

Worldwide Clinical Trials Ltd
Job LocationNottinghamshire
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

SUMMARY: To co-ordinate and perform validation and maintenance activities for WorldwidesGxP systems. To represent Worldwides 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 judgement 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
    • Required skills
  • Clinical Trials
  • Test Validation
  • Validation
  • GxP

    • Keyskills :
    Clinical Trials Test Validation Validation GxP

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