Compliance officer

We are looking for a self-motivated Compliance officer that wants be part of a professional team here in Cluj Napoca. Our partner is a global major player in dental industry.

Main responsibilities:

  • Improve computer system compliance within our partner
  • Ensures documentation and practices meet quality standards, applicable regulatory compliance and IS guidelines/policies.
  • Review user requirements, functional design specification, technical design specifications for clarity, good documentation practices.
  • Review the accuracy and completeness of software validation deliverables created by the project, functional process workstreams and the data migration, authorization and Infrastructure cross functional workstreams
  • Perform Validation and Qualification of GXP/Non GXP systems and infrastructure
  • Write and execute Computer System Validation (CSV) Protocols and Validation Summary Reports
  • Provide CSV expertise and risk analysis
  • Perform CSV GAP Analysis and develop the corresponding Remediation plans
  • Coordinate that software systems are implemented in conformance with CSV regulatory requirements and are in line with GAMP 5 standards
  • Supply technical guidance on global and local CSV policies and procedures

Requirements

  • Experience in Validation Engineering in FDA regulated Pharmaceutical or medical devices environment with concentration in Computer System Validation (CSV)
  • Experience with the design of Validation documents like Validation plan, IQ/OQ/PQ Protocols, Test cases and Traceability Matrix, Summary reports.
  • Knowledge of FDA 21 CFR Part 11, 50, 58, 210, 211, 312, 314 and 820 and general principles of Software Validation Life Cycle
  • Knowledge of ISO13485
  • Familiar with CSV compliant testing applications
  • Familiar with Infrastructure Validation is a plus
  • GxP advanced knowledge
  • GDPR basic Knowledge
  • Experience across the Microsoft Office Suite
  • Advanced skills in Microsoft Excel (pivot tables, macros, vlookups, complex formulas)
  • Advanced skills in Microsoft PowerPoint and Word
  • Experience of working in demanding and challenging environments
  • Experience of working to tight deadlines
  • Ideally some experience with large global transformation programs and the full project life cycle from a CSV perspective
  • Experience with CSV in an SAP S4 Hana environment
  • Highly organized and with an eye for detail
  • Happy to travel frequently
  • At least 5 years’ experience in a similar function
  • Strong verbal and written communication skills in English

   What we offer

  • The opportunity to contribute to our company
  • Professional training in a dynamic market with high growth potential as well as a diversified position
  • A pleasant working environment with helpful colleagues and a lot of space to be successful with us
  • Taking part in team buildings and social activities
  • Weekly massage
  • High standard equipment
  • Central location for our Office building
  • Other benefits will be discussed during the interview

Apply Online

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