CSV & DI Manager

CSV & DI Manager

Job Title: CSV & DI Manager
Contract Type: Contract
Location: Kent
Salary: Negotiable
Start Date: ASAP
Reference: CSV01_1490291045
Contact Name: Alex Young
Contact Email:
Job Published: March 23, 2017 17:44

Job Description

Main Objectives

  • Ensure all computer systems in the Quality Control Laboratory are validated as per 21CFR part 11. For all the rest of the Facility issue a VMP, assessing gaps and define actions to be fully compliant. For high risk systems assure closure of all gaps identified, in partnership with the Site Leadership Team
  • Define and implement practical methods to ensure data integrity compliance across the site


  • Responsible for assessing the current validation status of the Quality Control and Facilities related computer systems (e.g. Chromeleon, Malvern, FTIR, BMS, excel spreadsheets, etc…)
  • Define and implement a Computer System Validation Master Plan
  • Support the implementation of a Quality Management System (SOPs) for Computer System Validation and Data Integrity in partnership with the Quality Team
  • Write related validation protocol and reports
  • Implement a client data integrity strategy plan package
  • Responsible for PQ of Computer Systems

Education/ Qualifications

  • Education- Bachelor's degree in Engineering or related field

Technical Skills/ Experience

  • Knowledge of industry validation standards
  • 5-10 years of Computer Validation/ CSV experience within the Pharmaceutical/MHRA/FDA regulated industries
  • Experience in Lab instruments and enterprise IT systems
  • Demonstrated understanding and hands-on experience reviewing technical documents, including, validation documents, IQ/OQ/PQ validation protocols and reports

Other Skills/ Experience

Knowledge/Skills Requirements:

  • Strong communication, interpersonal skills, coupled with attention to detail, excellent review skills and analytical skills Ability to organise and prioritise work.
  • Ability to work under pressure to meet tight and changing deadlines
  • Ability to be assertive to ensure appropriate GMP and business standards are achieved
  • An accurate and systematic approach to work.
  • Ability to work unsupervised, be self-motivated and take the initiative to introduce new ideas.
  • Must be customer orientated
  • Must have good written and verbal communication skills.
  • A positive attitude to work.
  • Good analytical and writing skills.

  • Honesty and integrity.
  • Detail-oriented with ability to accomplish objectives.
  • Clear thinking/logical with strong personal organization skills.
  • Able to work within a diverse, cross-functional team in a matrix organizational environment.
  • Demonstrated competence in both written and verbal communication.

Business Environment:

  • Performance driven.
  • Collaborative and inclusive.


  • Shows personal drive and self motivation
  • Able to work with minimum supervision and to a high standard
  • Comfortable working as part of a small team
  • Work in a collaborative way.
  • Results orientated.
  • Positive, flexible and approachable.