Quality Assurance Operations Expert

C049 (FCRS = CH049) Novartis Pharma Schweizerhalle AG; Basel-Landschaft; Hybrid; CHF 85.000 - 159.000; Vollzeit

Benefits dieser Stelle

Hybrid working options

14 weeks parental leave

Total rewards program

Zusammenfassung

Novartis in Schweizerhalle, Switzerland seeks a QA Operations Expert to support GMP-driven analytics and GLIMS system, ensuring API quality and compliant change control.

The role covers QA SPOC for GLIMS, monograph change testing, lab deviations trend analysis, SOP authoring/review, self-inspections, and collaboration within ChemOps CH Quality. Fluency in German and English required.

Qualifikationen

• Education as Analyst with at least 3 years in the pharmaceutical industry.
• Analytical skills and excellent knowledge, especially regarding GLIMS.
• Experience in GMP environment.
• Proficient in German and English.

Aufgaben

• QA SPOC for GLIMS system.
• QA function for testing monograph creation/changes (change management process).
• Act as SME for analytical change control & lab investigation teams.
• SME for trending OOS/OOE/OOT and lab deviations.
• Subject expert for QM/QD/GOP gap assessments.
• Author and Reviewer for SOPs (e.g. QC/AST/Lab QA).
• Co-auditor for self-inspections in the analytical lab domain.
• Represent ChemOps CH Quality in working groups and scientific networks across Novartis.
• Review and approval of qualification documents for laboratory equipment along with the validation of the equipment`s associated software.

Kenntnisse

Analytical Skills

GMP experience

German language

English language

GLIMS knowledge

Ausbildung

Analyst education qualification

Bachelor’s Degree in Chemistry/Biology/Biotechnology or similar

Tools

GLIMS

Jobbeschreibung

Salary Range: CHF85,400.00 - CHF158,600.00

Job Description Summary #LI-Hybrid Location: Schweizerhalle, Switzerland

This role is based in Schweizerhalle, Switzerland. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

ChemOps Switzerland is an important part of Novartis Technical Operations focusing on the launch of inovative APIs. We work together with many partners to ensure products reach markets fast and in good quality. Therefore this job includes a broad range of diversified activities and interactions. As a QA Operations Expert you will support our laboratories in all GMP aspects allowing enough flexibility to ensure quick and agile launch services with the focus to ensure the quality of our APIs.

Major Accountabilities

• QA SPOC for GLIMS system
• QA function for testing monograph creation/changes (change management process)
• Act as subject matter expert for analytical change control & lab investigation teams
• SME for trending OOS/OOE/OOT and lab deviations
• Subject expert for QM/QD/GOP gap assessments
• Author and Reviewer for SOPs (e.g. QC/AS&T/Lab QA)
• Co-auditor for self-inspections in the analytical lab domain
• Represent ChemOps CH Quality in working groups and scientific networks across Novartis
• Review and approval of qualification documents for laboratory equipment along with the validation of the equipment`s associated software.

Obligatory Requirements

• Education as Analyst wit at least 3 years of experience in the pharmaceutical industry
• Analytical Skills and excellent knowledge, especially regarding GLIMS
• Experience in GMP environment
• Proficient in German and English

Desirable requirements

• Background in Analytics
• Bachelor's Degree in Chemistry, Biology, Biotechnology or similar

Rewards

At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen. The rewards of being part of our team go far beyond base pay and incentives.We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and a minimum of 14 weeks paid parental leave.

Expected Annual Base Salary Range for role: 85,400 - 158,600 CHF. The salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically. In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. Further details will be provided during the application process. Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.

Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.

Commitment to Diversity and Inclusion / EEO paragraph

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

Why Novartis

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Skills Desired Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.

In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov .