Quality Control Specialist II (m/f/d)

Novartis Holding GmbH

Summary

#LI-Onsite

Location: Schaftenau, Austria

Relocation Support: This role is based in Schaftenau, Austria. Novartis is unable to offer relocation support; please only apply if accessible.

As a QC Specialist, you will play a key role within the QCMD team, supporting reliable laboratory operations and ensuring compliance with high quality standards. Your responsibilities will include monitoring laboratory testing activities, supporting laboratory analysts, reviewing QC analyses, handling deviations, and contributing to GxP compliance, audits, and continuous process improvements.

You will help ensure that laboratory processes run smoothly, efficiently, and in line with regulatory requirements. Through your work, you will make an important contribution to the safe and reliable delivery of our products to patients.

About the Role

We are looking for candidates with relevant laboratory experience, very good German skills, good English skills, and a resilient, solution-oriented, and team-oriented working style.

Major Accountabilities

  • Oversee production and testing activities to ensure compliance with cGxP, including data integrity and eCompliance requirements.
  • Review and approve QC testing results, production documentation, QC records, and AS&T records.
  • Support exception, deviation, and investigation processes, ensuring timely follow-up and appropriate documentation.
  • Ensure QC activities are executed according to applicable GMP, GxP, regulatory, and internal quality standards.
  • Support batch release activities in compliance with GMP, registration, and license requirements.
  • Contribute to audit and inspection readiness, including support during GxP audits and regulatory inspections.
  • Ensure analytical equipment qualification, calibration status, and laboratory documentation are maintained according to requirements.
  • Support operational excellence and continuous improvement initiatives to improve quality, efficiency, cost, and delivery performance.

Obligatory Requirements

  • Education as a Lab Technician or similar qualification, or a university degree in a scientific or technical field such as chemistry, pharmacy, biology, or related discipline.
  • Professional experience in a pharmaceutical laboratory, QC, QA, analytics, or equivalent GMP-regulated environment.
  • Strong knowledge of GMP, GxP standards, quality control testing, quality assurance, and quality documentation.
  • Good understanding of laboratory equipment, analytical processes, data integrity, and compliance expectations.
  • Ability to manage ambiguity, and support investigations, deviations, CAPAs, and continuous improvement activities.
  • Good communication skills in German and English, with the ability to collaborate across QC, QA, production, AS&T, and operational teams.

Rewards

In addition to a market-competitive base salary, Novartis offers 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.

For this position the minimum salary is €59,781.96 EUR/year on a full-time basis. The expected annual base salary range for Austria is EUR 60,978.00 - 95,800.00 EUR.

Benefits may include insurance plans, retirement plans, wellbeing resources, global recognition programs, flexible and hybrid working options where possible, and a minimum of 14 weeks paid parental leave.

Read more about benefits and rewards: https://www.novartis.com/careers/benefits-rewards

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Novartis Holding GmbH

Jakov-Lind-Straße 5 Top 3.05
1020 Wien
Österreich