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Eso QA Expert

hace 3 meses

Barcelona, Barcelona, España Novartis A tiempo completo

10 days, that is how long we treat a patient's T-cells, before we return them to potentially save this patient's life.

To support such novel, personalized treatment by defining and implementing the microbial control strategy, is a unique challenge within Novartis with immediate patient impact.


  • As QA Expert you'll be responsible for leading a remediation project. Managing project aspects at external supplier (gap assessments, generation of source documents for regulatory purposes, management of change requests...) in compliance with cGMP, the Quality Assurance Agreement, regulatory requirements and the Novartis Pharma Quality Manual and is conducted according to the relevant SOPs.
    Please note that this role is temporary until 31st December 2023

Your responsibilities include, but not limited to:

  • Lead a project in alignment with the external supplier
as well as in close collaboration with an internal

  • Novartis manufacturing site.
  • Acts as Single Point of Contact / SPOC for all tasks
related to the project.- Ensure that all aspects of the project are in

compliance with the Novartis Pharma Quality

  • Manual, the effective Quality Agreement that they
- meet relevant cGMP regulatory requirements and
- are conducted according to local SOPs.
  • Responsible for driving the project as per the
defined plan. Execution actions to be adequately
- monitored to ensure gaps are suitably addressed
- and the deadlines for the key implementation
- milestones are achieved.
  • Provide the quality presence and input to technical
meetings with the External supplier and the internal
- manufacturing site. Establish good working
- relationships with clear communication and defined
- actions and goals.
  • Request, review and process GMP documentation
as defined by Novartis SOPs.- Escalate any issues as per the Novartis escalation

policy and initiate any market action that is required.

  • Support / participate in Novartis Emergency
  • Management cases as required.
  • Cooperate at the preparation of change requests
and ensures they are managed according to the

  • Quality Agreement and Novartis SOPs from receipt,
- through to the implementation and closure

Commitment to Diversity & Inclusion:

  • Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

Minimum requirements

Education:

University degree in pharmaceutical, chemical or other appropriate natural sciences
Languages:

English fluency required
Experience:
3 years of experience in quality management, regulatory affairs or quality control (preferred)
You'll receive:
Competitive salary, annual bonus, pension scheme, health insurance, flexible working arrangements, subsidized dining facilities, employee recognition scheme.
Why consider Novartis?
769 million. That's how many lives our products touched in 2020.

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

Division

  • Novartis Technical Operations

Business Unit

  • QUALITY

Country

  • Spain

Work Location

  • Barcelona Gran Vía

Company/Legal Entity

  • Novartis Farmacéutica, S.A.

Functional Area

  • Quality

Job Type

  • Full Time

Employment Type

  • Temporary

Shift Work

  • No

Early Talent

  • Yes