QA Operations Expert - PMO support for microbial projects

QA Operations Expert - PMO support for microbial projects

Location: Kundl | Type: Full time

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Job Description Summary

Ensure QA Operation activities in the area of responsibility are executed according to cGxP standards.

This role is limited until 30th of June 2026.

Job Description

Major accountabilities:

• Support technology transfer and OpEx improvement projects related to microbial production lines

• Ensure QA oversight and compliance with cGxP, incl. data integrity and eCompliance for the various projects

• Collaboration in cross-functional project teams

• Participation in and evaluation of changes in the process and specifications related to the projects

• Participation in the preparation and approval of validations, transfers protocols/reports and SOPs

• Approval of specifications, instructions for sampling, testing methods, Production Master Batch Records and other procedures in the area of responsibility

• Support, elaboration and approval of investigations on deviations, OOS / OOE

• Evaluation and approval of CAPA measures and risk assessments

• Preparation and participation in audits and inspections

Minimum Requirements:

• University degree in Engineering, Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology or equivalent

• At least 3 years or more experience in QC or QA or medical device industry

• Experience in operations management and execution

• Preferably experience in negotiations and global collaboration

• Fluent knowledge of English and German language (written and spoken)

• Flexibility to work in a fast paced, quickly changing work environment

• Ability to operate in a global matrix environment

• English and German language

You’ll receive:

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 € 64.023/ 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.

Skills Desired

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