Qc Specialist with Personnel Responsibility

vor 2 Wochen

Kundl, Österreich Novartis Vollzeit

**QC Specialist with Personnel Responsibility (f/m/d), Kundl, Tirol, Austria
**1 million doses of vaccine, that's the amount that one produced batch of NAFgamma delivers. In NAFgamma, one of the most modern manufacturing technologies is used with the mRNA production of active ingredients.
We are looking for an analytical expert/specialist in the area of quality control for the NAFgamma plant, supporting the laboratory team with in-depth knowledge to ensure efficient performance of laboratory activities and related investigations in compliance with GxP guidelines. Additionally, you will lead an supervise your own small team of Laboratory Technicians.

**Your key responsibilities**:
Your responsibilities include, but are not limited to:

- OOx/deviation handling, CAPA definition and KPI/KQI trending & analysis
- Ensure all activities are in compliance with GxP, incl. data integrity
- Review and approval of analytical data / tests (analytical release) as well as maintain and calibrate equipment incl. plan preparation
- Method set-up (incl. adaptation to ensure compliance with GxP), method validation and stability studies - protocol preparation, evaluation, report preparation
- Active involvement in costumer meetings and audits
- Leading and supervising your own team of QC Analysts (approx. 5 people)

**Commitment to Diversity & Inclusion**:

- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**

**What you’ll bring to the role**:
**Essential**:

- Analytical education and professional experience (3-5 years) in the pharmaceutical sector or in the manufacture of active substances in analytical laboratories in a GMP environment or equivalent
- Collaboration and result oriented; efficient in inter and intra-departmental communications
- Experience in leading teams is an advantage
- Fluent in German and English (oral and written)
- University degree in Chemistry, Biology, Pharmacy or equivalent
- Knowledge in laboratory equipment (particularly HPLC, UV-/Fluorescence Spectroscopy, Gel Electrophoresis)
- Experienced in Quality Control (QC) and knowledge of industry GxP standards and processes

**Why Novartis?**

769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying

**Imagine what you could do here at Novartis
**In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities 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 € 54.735 /year (on a full time basis). We also offer a potential market oriented excess payment in line with your experience and qualifications.
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 work environment and diverse team’s representative of the patients and communities we serve.
Our recruitment decisions are based on selecting the best person for the job, regardless of gender, religion, age, colour, race, sexual orientation, nationality or disability.

**Applicants with Disabilities**:
**Division**

Operations

**Business Unit**

QUALITY

**Country**

Austria

**Work Location**

Kundl

**Company/Legal Entity**

Sandoz GmbH

**Functional Area**

Quality

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

Yes

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