Analytical Science
7 mesi fa
The AS&T Lead leads the Site’s AS&T organization, which is responsible to maintain and improve the scientific oversight of the Quality Control processes and technical changes. Ensure the timely execution of AS&T activities in compliance with cGMP legal and regulatory requirements and with Novartis Corporate Quality Manual and Policies.
**Your key responsibilities**:
Your responsibilities include, but are not limited to:
- Set objectives and develops vision for department.
- Act as SPOC for Quality Control head and AS&T platform/cluster head.
- Manage the AS&T career path, succession planning, training program and career progression within the site.
- Define and implement standards for AS&T (e.g. local SOPs, templates).
- Provide expertise and support to the Quality and Process Units on technical, analytical and organizational procedures.
- Analytical Development groups to ensure that newly developed analytical methods are robust and effective in the commercial laboratory environment.
- Leads the AS&T group and ensures the development of the team members in technical and leadership skills while maintaining a good communication culture within the team.
- Evaluates and implements new technologies required to maintain state-of-the-art analytical methods for development and market products.
- Involvement in investigation of deviation, OOS/OOE/OOT regarding QC department, change controls, CAPA implementation, redaction and execution of training.
- Preparation and participation in inspections and audits.
**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._
**Minimum requirements**
**What you’ll bring to the role**:
- Scientific Master Degree.
- At least 5-year experience in analytical laboratory, method development, qualification of HPLC, GC, TLC,ecc.
- Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
- Thorough understanding of analytical methods and related equipment.
- Expert in reviewing and writing technical reports.
- Previous experience in a sterile manufacturing environment desirable.
- Fluent in English. Proficient in Italian.
Work location: Colleretto Giacosa (TO).
**Why Advanced Accelerator Applications?**
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications, a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying Imagine what you could do here at Novartis
**Imagine what you could do at Novartis**
**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**
No
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