Aseptic Process Lead Colleretto Giacosa

3 settimane fa

Colleretto Giacosa, Italia Novartis A tempo pieno

**AAA Statement**

**Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients’ lives by leading innovation in nuclear medicine.**

**AAA offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE).**
- The purpose of the role:

- The Aseptic process Lead is responsible for maintaining, managing, support and continuously improving the aseptic process, in collaboration with all site departments for the operational area assigned, and back up for the other one, and following Risk Assessment Principles and Continuous Improvement Concept
- Main responsibilities:
- Support aseptic training certification and other specific trainings related to Microbiology and Contamination Control Strategy.
- Develop, qualify and implement microbiological test methods to support sterility assurance of products;
- Review sterilization and laboratory documentation to ensure compliance with procedures;
- Lead or participate in auditing contract labs and sterilizers;
- Lessons Learned and Best Practice sharing related to aseptics.
- Lead the implementation of new standards or regulations related to aseptics and contamination control.
- Support audits and regulatory inspections during the execution and preparation the answers to the possible observations or finding detected.
- SME role for the topics assigned related to aseptics,

especially for the Continuous Improvement projects
- related to critical areas within the Plant ( Utilities,
- Steam, Water, PNV, Biofilm Risk etc)**Commitment to Diversity & Inclusion**:

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

**Minimum requirements**
- What you will bring to the role:
- University or academic degree in Chemistry, Biology,

Pharmacy or equivalent- English fluently, verbally and in writing
- Min. 5 years’ experience in the pharmaceutical industry

focus on sterile business, preferably in a FDA
regulated environment (Sterile, Solids, API and Drug
- Products) and in QA Operations & Compliance Quality
- Assurance / cGMP regulations in USA, EU (Self
- Inspections, Complaint/Deviation Handling, GMP
Training, SOP-Systems).

**Division**
- Oncology

**Business Unit**
- ADVANCED ACCELERATOR APPLICATIONS

**Country**
- Italy

**Work Location**
- Colleretto Giacosa

**Company/Legal Entity**
- AAA Italy Srl.

**Functional Area**
- Quality

**Job Type**
- Full Time

**Employment Type**
- Regular

**Shift Work**
- No

**Early Talent**
- Yes

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