IT Quality Manager
Praha, Česká republika
před 1 dnem

For our client, company that delivers innovative IT services of outstanding quality and value, we are looking for suitable candidates on the position IT Quality Manager .

Your responsibilities :

  • Lead and advise on quality activities (from initiation to completion on IT Projects) within the pharma / life sciences sector
  • Creation and / or review and management of the designated validation deliverables such as System Risk Assessments, Validation / Qualification Plan and respective reports
  • Apply the specifications of the customer’s Quality Systems and Standards to ensure that the quality of processes and deliverables of both projects and services meet their specified corporate and regulatory requirements
  • Ensure computerized systems comply with all applicable GxP regulatory and customer’s requirements throughout the life cycle for the systems
  • Liase with a wide range of Subject Matter Experts, including QA, Security, Data Privacy, Legal, and others to ensure high quality delivery
  • Facilitate risk identification, assessment and mitigation planning for computerized systems
  • Your profile :

  • University degree (Bachelor or Master) in Technical / Life Science, ideally enhanced by international work / study experience in an area relevant to Quality and Project Management
  • Minimum of 5 years of experience in IT projects, Project Management, Quality Management including change management, risk assessments and risk management in the in the regulated Pharmaceutical Industry.
  • Deep expertise in US FDA cGxP regulations, EU-GMP-Guide Annex 11 and US FDA 21 CFR Part 11 requirements & strong background with Quality Management and Computerized Systems Validation (CSV) aspects of application implementations and operations in the regulated Pharmaceutical Industry.
  • Experience of Agile methodology for CSV and / or Software Development Lifecycle (SDLC)
  • Able to work with a high degree of autonomy and self-management, being able to proactively find solutions to problems and knowing when to appropriately escalate issues
  • Self-confident and assertive with excellent interpersonal and communication skills and the ability to demonstrate initiative and a flexible working style within a multi-national team
  • Fluency in English (additional languages (e.g. German) advantageous) and the ability to communicate clearly and professionally, both verbally and in writing is essential
  • Previous experience from Novartis and ICE certification is a big plus
  • Place of work : Prague, foreign countries

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