Process Quality Expert GxP and SaMD
Prague, Czech Republic
před 9 hodinami

Job Description

Process Quality Expert GxP and SaMD, Novartis, Prague, Czech Republic

Coordinate, control and monitor changes to the systems environment for an IT operational area to ensure operational stability.

Plan and execute service transitions. Manage the software change cycle and ensure maintenance of the service catalog to reflect changes.

Your key responsibilities :

Your responsibilities include, but are not limited to :

  • Coordinate, control and monitor changes to the systems environment to ensure operational stability.
  • Plan and execute service transitions as well as post transition activities, confirming that there are defined service commitment points for each transition program.
  • Track service readiness documents are created and accepted by stakeholders and that transition risks are identified and mitigated.
  • Ensure up-front planning, scheduling, and successful deployment of releases to production environment in a controlled and systematic way so as to meet service levels and avoid any impacts on existing services.
  • Ensure that all release and deployment packages can be tracked, installed, tested, verified and backed out (if required).
  • Conduct service handover and lead the go live authorization discussions with the other work streams.
  • Maintain operational service catalog and ensure consistency between the catalog and the overall service portfolio.
  • Minimum requirements

    What you’ll bring to the role :

  • Expertise in various SDLC models like V-Model, Agile, Waterfall, SCRUM
  • Experience in working with Agile tools like JIRA / Confluence or equivalent
  • Expertise in GAMP, Pharma Quality, Validation, GxP
  • Experience in SAMD(Software as a Medical Device) processes, proven working experience in Medical devices qualification, Validation
  • Expertise in writing SOPs, Process documentation is a must
  • Certifications around GxP, Quality processes, SDLC / ITIL preferred.
  • You’ll receive :

  • Monthly pension contribution matching your individual contribution up to 3% of your gross monthly base salary; Risk Life Insurance (full cost covered by Novartis);
  • 5-week holiday per year; (1 week above the Labour Law requirement) ; 4 paid sick days within one calendar year in case of absence due to sickness without a medical sickness report;
  • Cafeteria employee benefit program choice of benefits from Edenred CZ in the amount of 12,500 CZK per year; Meal vouchers in amount of 90 CZK for each working day (full tax covered by company);
  • Car Allowance; MultiSport Card. Find out more about Novartis Business Services : https : / / /

    Why consider Novartis?

    799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this : how can we continue to improve and extend even more people’s lives?

    We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment.

    Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

    Imagine what you could do at Novartis!

    Commitment to Diversity & Inclusion :

    Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

    Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.

    Join our Novartis Network : If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here : https : / / / network

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