Microbiological Quality Control Manager

1 settimana fa

Saluggia, Italia Novartis A tempo pieno

**Summary**:
The Micro QC Manager ensures that Biological and Microbiological Quality Control processes for materials acceptance, environmental checks, batches quality control and related equipment validation/qualification are executed and fully compliant to cGMPs regulation, corporate and national guidelines.

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

- Support the preparation for and execution of internal and Health Authorities inspections.
- Approve or discard raw materials used for manufacturing of products and all semi-finished products and finished products.
- Immediately notify any substantial irregularity detected in the product that has already been placed on the market.
- Support technological and organizational interventions aimed at the improvement of manufacturing processes in terms of quality, productivity and costs and the optimization of the resources relating to the site.
- Support the development and implementation of projects related to new or existing products.
- Ensure the compliance with the rules of hygiene and safety and protection according to cogent law.
- Monitoring the stability trend of the products.
- Approve/verify the Quality Control Documentation (specifications, sampling and control methods, procedures) related the belonging area.
- Guarantee, for its own area of competence, that every equipment used is correctly qualified and under instrument lifecycle control.
- Guarantee, for its own area of competence, that the analytical methods are correctly validated and under analytical method lifecycle control.

**Essential requirements**:

- Degree in Biology, Microbiology or Biotechnology.
- Previous experience in managing a team of people within a Microbiology laboratory.
- Excellent organizational skills (time management, risk management) including attention to detail and multitasking skills.
- Fluent in Italian and English.

Division

Operations

Business Unit

Innovative Medicines

Location

Italy

Site

Saluggia

Company / Legal Entity

IT58 (FCRS = IT058) Advanced Accelerator Applications Italy Srl

Functional Area

Quality

Job Type

Full time

Employment Type

Regolare

Shift Work

No

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