Quality Assurance Specialist Milano

Quality Assurance Specialist
Milano
Lombardia, Milano

Summary**:

- Manages Quality aspects and projects within area of responsibility. -Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems. Prepare Documentation for Batch Release of commercial Pharmaceuticals

**About the Role**:

**Major accountabilities**:

- Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance -Support exception investigations -Review and approval of production, QC, and AS and T records -MBR review -Support OpEx improvement projects Qualified Person - Executes batch release in compliance with registration -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

**Key performance indicators**:

- On-time and GMP-compliant release of dosage forms -No complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand -Successfully support continuous improvement projects -Executes batch release in compliance with registration

**Minimum Requirements**:

**Work Experience**:

- Functional Breadth.

- QC/ QA in pharmaceutical ind. / biotech with environmental monitoring &.

- Collaborating across boundaries.

- cleanliness zones.

**Skills**:

- Continuous Learning.

- Dealing With Ambiguity.

- Gmp Procedures.

- Qa (Quality Assurance).

- Quality Control (Qc) Testing.

- Quality Standards.

- Self Awareness.

- Technological Expertise.

- Technological Intelligence.

**Languages**:

- English.

Division

Operations

Business Unit

Innovative Medicines

Location

Italy

Site

Milano

Company / Legal Entity

IT08 (FCRS = IT008) Novartis Farma S. p. A.

Alternative Location 1

Remote, Switzerland

Functional Area

Quality

Job Type

Full time

Employment Type

Temporary (Fixed Term)

Shift Work

No

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