IT Compliance & Validation Manager

Recruiter
Arjo Med AB Ltd
Location
Dunstable
Salary
£50,000 - £60,000
Posted
31 Oct 2017
Closes
16 Nov 2017
Contract Type
Permanent
Hours
Full Time

IT Compliance & Validation Manager

Position: IT Compliance & Validation Manager
Location: Houghton Regis
Hours: Monday - Friday 9am - 5pm
Salary: £50,000 - £60,000
Bonus: 15% - 20% paid annually in March

ROLE:

A global medical devices company are looking to recruit an IT Compliance & Validation Manager to ensure the compliance of all Group Information Systems and make sure that good Computer System Validation (CSV), Change Control and Good Document Practices (GDP) are applied in accordance with internal ECDs, SOPs and external regulations.

You will review and support QRC in the frameworks for Customer Systems Validation (CSV) in compliance with Regulatory Authorities? requirements and recognizes technical standards.

RESPONSIBILITIES:

  • Ensure that processes needed for IT are established, implemented and maintained.
  • Promote awareness of the Quality Management System (QMS) and GxP Documentation Practices within IT service suppliers.
  • In conjunction with Global QRC be responsible for Computer System Validation (CSV) process and quality control of the CSV process for Global new and existing information systems.
  • Manage the IT M3/SAP Change Control process
  • Guide project teams in the creation of all items of CSV documentation, ensuring that they meet the QMS requirements.
  • Ensure that the Computer Software Validation Files are maintained correctly.
  • Support development, documentation and maintenance of IT/ IS procedures.

KNOWLEDGE / EXPERIENCE:

  • Experience of GxP Documentation Practices.
  • Experience of Validation V Model (GAMP5).
  • Experience of FDA regulatory requirements with respect to Information Systems (21 CFR Part 11).
  • Experience of using and documenting ERP systems.
  • Clear understanding and experience of documentation control.
  • Good written and verbal communication skills and ability to maintain clear procedures.
  • Ability to liaise with a wide range of internal and external stakeholders across all levels of the business.
  • Ability to work under pressure, to tight timescales and to adapt to changing work demands.
  • Ability to work on your own or as part of a team.
  • Personal computer literacy is pre-requisite with experience of Microsoft e.g. Word, Excel, Power point and Outlook.
  • Must be able to work on their own initiative and effectively manage their own time as well as manage the workload of team/department.
  • Must be able to liaise with Personnel both on and off site.

You must have knowledge of working with CSV projects, project management and holding training courses/presentations. You will also need to have good knowledge in applicable regulations and standards, e.g. ISO 9001, ISO 13485, FDAs QSR and GAMP


This job was originally posted as www.jobsite.co.uk/job/959398956