QA Specialist Operations

Job Description Summary

QA Operations Specialist in the Raw Material & Consumables Release Group.

 

Job Description

Major accountabilities:

• Release preparation (collection and completion of data, documents and information) & coordination & troubleshooting (interactive communication & release organization)

• QA compliance support (audits for DSK/DSS/DPS, submissions etc.)

• Project support (support of new labs, departments, systems into routine etc.)

• Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance; support exception investigations
• Support of master data systems at our production site: SAP, GLIMS etc.; responsible for CP implementations and stability studies
• Compilation / check of master data sheets (master data maintenance); Change evaluations / implementation tasks, being a SPOC/SME for all related topics
• Responsible for material implementations (raw materials, consumables etc.), troubleshooting & Project support
• Key performance indicators: deliver preparation on time, support raw material and consumables release and projects

Minimum Requirements:

• QC/ QA in pharmaceutical ind./ biotech with environmental monitoring
• Experience with GMP Procedures, Quality Assurance (QA) and Quality Control (QC) testing, Quality standards
• Technological Expertise and technological Intelligence
• Required skills: Dealing with ambiguity, able to learn continuously, collaborating across boundaries
• 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 € 58.199,96/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

Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence