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: over 2 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

W1siziisijiwmtcvmdivmtuvmtyvntivmjuvnzkwl2n5ymvyigf0dgfja3muanbnil0swyjwiiwidgh1bwiilcizodb4mtawiyjdxq

UK threatened by serious cyber attacks every ...

2017-02-15 16:00:00 +0000

The security of the UK has been threatened by 188 serious cyber attacks in the last three months, a government security chief has said. National Cyber Security Centre (NCSC) Chief Executive Ciaran Martin told The Sunday Times that national security was put at risk by many of these attacks. Martin was speaking ahead of the official opening of the NCSC, which has been set up to protect critical services in the UK from such attacks and improve underlying i...

W1siziisijiwmtcvmdivmdgvmtavmzcvmzkvnjkyl0n5ymvyifnly3vyaxr5lmpwzyjdlfsiccisinrodw1iiiwimzgwedewmcmixv0

British cyber security workforce rises 163%

2017-02-08 10:00:00 +0000

Data from the UK has shown that the cyber security workforce has grown considerably over the past five years. According to a new report from cyber skills promotion network Tech Partnership, there are now 58,000 more workers in this industry – a rise of 163 per cent. It shows the growing importance of these professionals, with firms across a vast range of industries turning to cyber security specialists to safeguard their data. To collate the report, the...