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QA Operations Expert

Role overview

Qualifications

  • Minimum bachelor degree or equivalent in life sciences or equivalent discipline (bioengineering, pharmacy, medical, biology, chemistry, etc.)
  • Minimum 2 years of QC experience
  • Knowledge of GMP and GDP standards and processes
  • Risk Management and Quality Decision Making

Responsibilities

  • Support monitoring, tracking and evaluation of the material release setup
  • Lead and support DEV, OOx and complaint investigations
  • Ensure timely and compliant release of raw material consumables
  • Oversee all non-conformity issues related to raw materials released

Key facts

Other skills

  • Quality Control
  • Investigation
  • Collaboration
  • Verbal Communication Skills
  • Leadership
  • Problem Solving

About the company

Novartis logo

Novartis

Pharmaceutical Manufacturing

Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. Find out more at https://www.novartis.com See our community guidelines: https://go.novartis.social/3Nboxki

Company details

Company typeXLarge
IndustryPharmaceutical Manufacturing
Company size10001

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Job description

Job Description Summary

Responsible for QA release activities in context of raw material and consumables release. Handling of quality relevant events (DEV, OOx, complaints, etc.).

This position if open for 80% - 100% employment.


 

Job Description

Major Accountabilities:

  • Support monitoring, tracking and evaluation of the material release setup, contribute to the IIA KPI and RCI processes
  • Lead and support DEV, OOx and complaint investigations and promote quality relevant topics and projects in scope
  • Complete personal trainings in due course
  • Ensure timely and compliant release of raw material & consumables, including:  Make release decisions for raw material & consumables
  • Oversee all non-conformity issues (OOS, OOE, OOT, deviations, complaints) related to raw materials released
  • Drive consistent and efficient operation of the quality operations function in the area of responsibility
  • Seek opportunities for productivity improvements, and coordinate their implementation
  • Support to health authority inspections and customer audits

Minimum Requirements:

  • Minimum bachelor degree or equivalent in life sciences or equivalent discipline (bioengineering, pharmacy, medical, biology, chemistry, etc.)
  • Minimum 2 years of QC experience
  • Knowledge of GMP and GDP standards and processes
  • Risk Management and Quality Decision Making
  • Required skills: Dealing with ambiguity, able to learn continuously, collaborating across boundaries and Change Management
  • English and German language required

Why Novartis?

Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You’ll receive:

You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 65.605,54/year (on a full-time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.

We are open for part-time and job-sharing models and support flexible and remote working where possible.

Commitment to Diversity & Inclusion:

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

Adjustments for Applicants with Disabilities:

If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to disabilities.austria@novartis.com and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.

Join our Novartis Network:

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


 

Skills Desired

Collaboration, Communication Skills, Continuous Improvement mindset, Data Integrity, Dealing With Ambiguity, Digital saviness, Leadership, Problem Solving Skills, Regulatory Requirements knowledge

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Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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