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Quality Control Specialist – Cork Cork Ireland,  

Project Prochem (company)


Posted on : 15 March 2019

Project Description

role summary:

 

  • provide it Compliance/Validation support to the ermd/ait team.
  • ensure Compliance with computer systems Validation (csv) and systems development lifecycle (sdlc), cyber security and data integrity.
  • prepare plans for remediation of legacy systems and implementation of new systems
  • deliver effective and efficient running of csv Compliance Operations in the ermd/a&it team.
  • provide Compliance support, guidance and expertise.

 

experience:

 

  • providing ongoing it Compliance/csv support.
  • become sme of sdlc/csv policies and procedures.
  • ensure supply of all Compliance components required to deliver high quality product through tactical Planning and execution of project and Compliance deliverables; including change-control, cyber security, data integrity, Training etc.
  • generation and execution of documents such as user requirements specifications, design specifications, fat, sat, iq, oq, pq etc.
  • ensure highest quality & Compliance standards.
  • participate and comply with Quality Management System (qms) requirements and regulations, including: eu annex 11, 21 CFR Part 11, mhra (uk) GMP data integrity guidelines, sarbanes-oxley (sox ) regulations.

 

minimum qualifications and experience:

 

  • appropriate 3rd level Qualification desired.
  • previous experience in a similar role within a highly regulated environment.
  • pharma experience essential.
  • exceptional organizational skills.
  • excellent Communication Skills.

 

to apply:

 

if you would like to discuss this vacancy or to discuss your Career and other job opportunities in confidence, contact us:

gc north valley business centre, old mallow road, cork, t23 kc67, ireland.

+353 21 2066178
recruitment@prochem.ie

click here to submit your cv

Locations

Cork, Ireland

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