Data Integrity Project Manager - 12-18 month FTC

Recruiter
Harris Lord Recruitment Limited
Location
Thames Ditton
Salary
£60,000 - £75,000
Posted
10 Nov 2017
Closes
16 Nov 2017
Contract Type
Permanent
Hours
Full Time

Data Integrity Project Manager
Healthcare / Pharmaceuticals
12-18 month Contract
South West London

Our client is a well-established healthcare business with a long history providing well-known brand name products. An opportunity as a Data Integrity Manager has arisen to project manage the implementation of Data Integrity. Working to strict standards such as EU Annex 11 (GMP_ and CFR Part 11 for IT Systems.

A successful candidate will be expected to lead, develop and execute the implementation plan, working with relevant parties across the business. Developing SOP?s to provide a framework for Data Integrity, working closely with the Quality, Technical and IT Leadership teams to ensure procedures are achievable and sustainable.


Key Responsibilities/Duties

  • Develops the DI implementation plan in line with GMP and the company DI Policy in compliance with EU Annex 11 (GMP) and CFR Part 11 for IT systems.
  • Works closely with Heads of Quality, IT, Technical, Operations and the QC Lab Manager to prioritise activities required, and agree support required and completion dates.
  • Identifies and prioritises changes required to infrastructure and equipment. Helps to develop specifications and validate the new solutions.
  • Arrange and co-ordinate training for staff during implementation of new DI procedures and activities.
  • Where 3rd party support is required, co-ordinates work with Integrity Solutions.
  • Implements key performance metric to track progress of DI implementation.
  • Maintains up-to-date knowledge of the relevant regulations affecting DI.
  • Creates and maintains a DI infrastructure for documentation and validation
  • Writes protocols for data integrity testing and ensures activities are carried out correctly and meets test criteria/regulatory standards.

Experience

  • GMP experience within pharma or healthcare regulated environment.
  • Experience of implementing DI within either pharma or healthcare, to meet relevant regulations.
  • Experience in computer systems validation.
  • Experience of educating staff on DI.
  • Experience in developing and implementing procedures to ensure compliance to applicable regulations.

Skills and Abilities

  • Strong project management skills.
  • Good influencing skills and demonstrable ability to build a project plan with buy-in from relevant functions and executed against an agreed schedule.
  • Ability to drive improvement and make changes to existing working practices.
  • Professional, confident, bright, ability to work on own initiative, self-motivated.
  • Good written and oral communication skills.
  • Pragmatic and able to adhere to deadlines.

Please click apply now!

Harris Lord is acting as an employment agency on this role.


This job was originally posted as www.jobsite.co.uk/job/959509117