Quality Control Specialist – Cork Cork Ireland,
Project Prochem (company)
Posted on : 15 March 2019
- 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.
- 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.
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
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