Worldwide Clinical Trials

Senior Validation Analyst

Location
Nottingham, GB
Salary
Competitive
Posted
11 Sep 2020
Closes
25 Sep 2020
Ref
969
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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

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