CSV Engineer

Basel  ‐ Vor Ort
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Beschreibung

CSV Engineer

Referenz-Nr.: 5316KS

Branche: Medical

Einsatzort: Basel und Region

Beginn: Juni 2015

Dauer: bis Ende 2015

Pensum: 100%

Aufgabenbereich:
  • Understanding of software validation requirements with respect to Data Integrity, security , GAMP guidelines and the requirements of 21 CFR Part 11.
  • Understanding of documentation change control, review, approval and archiving requirements and the ability to ensure procedures are efficiently and consistency applied.
  • Ensure Business Processes & Validation Master Plans are established and updated where necessary
  • Approve and compile where appropriate CSV protocols and reports.
  • Develop templates and write/edit validation documentation as required.
  • Manage the IQ, OQ & PQ process for the project team.
  • Track and resolve exceptions during qualification activities.
  • Prepare reports of executed protocols for review.
  • Prepare and/or update standard operating procedures, Operation Handbooks and ensure they are reviewed in a timely manner with respect to CSV.
  • Work closely with Quality Assurance and system owners to effectively implement system upgrades, or system modifications.
  • Produce reports on validation activity, utilizing knowledge and experience to effectively communicate results to stakeholders.
  • Prepare, maintain, and review validation documentation.
  • Complete and review quality systems risk assessments.


Anforderungen:
  • 3-5+ years of working experience in IT Quality CSV operations or compliance
  • 2-3 years test and deviation management
  • Detailed knowledge and understanding of CSV, 21 CFR Part 11 and GAMP
  • Excellent technical writing ability
  • Good written and verbal communication and presentation skills


Sprachkenntnisse: bilingual German and English language skills mandatory
Start
04/2015
Dauer
6 Monate
Von
ITech Consult AG
Eingestellt
22.04.2015
Projekt-ID:
889449
Vertragsart
Freiberuflich
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