Connecting to LinkedIn...

Connecting to LinkedIn...

W1siziisijiwmtqvmdkvmzavmtavndevmzevmzkxl3n0b2nrx3bob3rvx2pvynnfynv0dg9ux29ux2tlewjvyxjkxzgwmdu4mtgxlmpwzyjdlfsiccisinrodw1iiiwimtkymhgxmjuwiyjdxq

IT Compliance Lead

Job Title: IT Compliance Lead
Contract Type: Permanent
Location: United Kingdom,Southampton
Industry:
Salary: £60000 - £70000 per annum + package
Start Date: Immediate
REF: ITCOMPLIANCELEAD1_16974
Contact Name: Jack Skinner
Contact Email: jacks@montash.com
Job Published: about 3 years ago

Job Description

Responsibilities:

  • Lead the development and maintenance of processes and standards for the R&D IT organisation referring to appropriate industry standards e.g. COBIT, ITIL, GAMP5 and regulations e.g FDA, MHRA, EC.
  • Facilitate the maintenance and deployment of the IT Quality Manual and Systems Development Lifecycle for R&D IT
  • Provide guidance to enable the organisation to apply standards / meet regulations and to address non-compliance issues on the use of computerised systems proportionately to their impact and the needs of the business
  • Support IT Delivery in the use of the SDLC to assess, plan, coordinate and perform the computerised systems validation of systems being implemented, from project inception with IT Demand through to handover with IT Services including
  • Criticality and Business Risk Assessment of requirements
  • Validation PlanninG
  • Design Review
  • Test Planning (including design and scripting of functional testing)
  • Traceability of validation activities through to design/configuration, and testing.
  • Validation Reporting and hand-over to system owner and IT Service
  • Maintain the state of 'inspection readiness' by regular and ad-hoc review of IT's compliance state, outstanding corrective actions, and identifying preventative actions to prevent issues arising during inspection.
  • Act as primary contact during regulatory inspections for any matters relating to the control of computerised systems.

Experience/Skills:

  • The role requires strong Audit, Risk and Controls skills; strong interpersonal and engagement skills at internal and external levels are essential.
  • Degree Educated, with 8-10 years post graduate work experience in a Pharmaceutical/Life Sciences/Medical Device Industry
  • Experience of specific industry best practice

Social Stream

Latest News

W1siziisijiwmtcvmdcvmtgvmdgvndcvmduvntu5l2jpz3n0b2nrluv4b3rpyy1qyxjhzglzzs1ucmf2zwwtvg91cmktmtc2mju4ndm3lmpwzyjdlfsiccisinrodw1iiiwimzgwedewmcmixv0

Getting Ready to Switch Off

2017-07-17 09:00:00 +0100

According to research by online travel company Expedia, just 53% of workers come back feeling rested after they’ve been on holiday. When you bring work-related stress on holiday with you, you’re never going to be able to truly switch off. So if you've got a summer holiday coming up, what should you do to switch off and unwind? Before you leave... Plan ahead As soon as you know when your last day of work is, make a plan. You don't want to get to that fin...

W1siziisijiwmtcvmdyvmzavmtyvmtgvmjavmtg5l3nodxr0zxjzdg9ja182njkxody3mdkuanbnil0swyjwiiwidgh1bwiilcizodb4mtawiyjdxq

In Her Shoes... SAP Contracting

2017-07-03 09:00:00 +0100

In IT, being a freelancer is very common; due to the nature of project work or other life commitments. SAP is an area in which a quality freelancer can really thrive. We sat down with one of our SAP freelancers, who has 20 years' experience, to find out more about SAP and working under a contract employment model. "After getting a degree in computing, I started my career as a training assistant, but I've always liked to fix things. I used to fix my own ...