Process Expert
7 giorni fa
393568BR
**Process Expert**:
Italy
**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.
**
**Advanced Accelerator Applications 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).
**
**About the role**
The Process Expert will provide front line expert support for all process-specific issues to production within one or more production steps, to ensure execution of processes on time, continuously improving in quality and productivity, performed in compliance to cGMPs, SOPs and applicable guidelines and functional standards.
**Your key responsibilities**:
Your responsibilities include, but are not limited to:
- Provide front line support to manufacturing, working with the shift teams, focusing on manufacturing each batch safely, on time, in compliance with the batch instructions and quality requirements.
- Responsible for maintaining the master manufacturing documents of assigned products (e.g.
Master Batch Record, Bill of Material (BOM) & Recipe, Quality Risk Assessment).
- Ensure that all process changes in assigned products are managed through appropriate change control procedure.
- Act as Subject Matter Expert (SME) for the product and process knowledge, be highly knowledgeable of product and process trends by providing input to APQR for analysis and for driving process technology innovations.
- Support the execution of process validations, and short-term improvement projects, liaising with all the relevant parties at shop floor to ensure accurate execution.
Manufacturing Excellence
- for the product(s) assigned.
**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._
**Role Requirements**
**What you'll bring to the role**:
- Previous relevant experience in process support role on the shop floor of GMP manufacturing and/or QA/QC.
- Proven process understanding (Pharma, GMP, Regulatory aspects).
- Italian proficiency and fluent in English.
Work location: Colleretto Giacosa (TO).
**Division**
Oncology
**Business Unit**
ADVANCED ACCELERATOR APPLICATIONS
**Work Location**
Colleretto Giacosa
**Company/Legal Entity**
AAA Italy Srl.
**Functional Area**
Technical Operations
**Job Type**
Full Time
**Employment Type**
Regular
**Shift Work**
No
**Early Talent**
Yes
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