Qc Specialist Ii

vor 2 Monaten

Langkampfen T, Österreich Novartis Vollzeit

**Summary**:
We are looking for a highly skilled and experienced laboratory professional who contributes to the Good Laboratory Practice by ensuring efficient and timely review of laboratory analyses, compliance to industrial standards, investigation of deviations and complaints, training of personnel and coordination of device maintenance.

**About the Role**:
**Major accountabilities**:

- Preparation of protocols and associated reports (e.g device qualification)
- Training of laboratory personnel
- Participation of SOP authorship
- Support in preparation and implementation of regulatory inspections and audits
- OOx/Deviation handling and CAPA definition
- KPI trending
- Review and approval of analytical tests (analytical release). Ensure all activities in compliance with cGxP, incl. data integrity review and approval of analytical data / tests (analytical release) Stability -Stability testing (Projects) - protocol preparation, evaluation, report preparation.
- Reporting (Stability plan preparation, trend analysis, evaluation)
- Performance of Stability studies, protocols and comparative reports for supplier qualification
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
- The relevant KPIs that are defined in the Quality Control areas apply: e.g. analytical lead times: Timely and GMP-compliant analysis & documentation of the results.
- Error rate: Number of OOS (analysis errors) related to the number of analyses
- Individual performance is assessed using the PMP performance dialog together with the manager

**Minimum Requirements**:

- BSC or MSc in natural sciences with 4 years of relevant experience in Pharma/Manufacturing sector in analytical lab, or PhD with 2 years of experience.
- Continuous Learning, dealing With Ambiguity, decision Making Skills.
- Experience with Industry Standards and Quality Control (QC) Testing, laboratory Equipment, Quality Control Sampling, GMP.
- Fluent in both German and English, both written and spoken.

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 may be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.

**Commitment to Diversity and Inclusion**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Division

Operations

Business Unit

Innovative Medicines

Location

Austria

Site

Schaftenau

Company / Legal Entity

AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH

Functional Area

Quality

Job Type

Full time

Employment Type

Regular

Shift Work

No

**Adjustments for Applicants with Disabilities**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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