Quality control

Fed*** ***** (XX Anni)
Quality Control Spv a Aenova group
Galileo Galilei
Aprilia,
Lazio
Questo candidato e' disposto a spostare
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Esperienza
Quality Control Spv
Aenova group
giu 2021 - Attualmente
- Leading and prioritizing the day-to-day operations of the QC Laboratory with over 30 FTE in staff;
- Ensuring high quality in the conduct of all laboratory activities, data summary and interpretation,
report preparation and review. Reviewing and approval of laboratory data, protocols and reports.
- Equipment qualification and Troubleshooting
- Leading and conducting Customer and Regulatory audits
- Constant Support on Customer decisions and proposals
- Laboratory Investigation using a 6M approach
- Support on:
- Management on New Project;
- QA Manufacturing Investigations;
- Product Development Reformulation; - Cleaning and Process Validations;
Analytical Development Spv
Catalent Italy SPA
mar 2004 - mag 2021
- Leading and prioritizing the day-to-day operations of the AR&D department and Quality Control Laboratory
- Leading with expertise the development, validation and transfer activities
- Ensuring high quality in the conduct of all laboratory activities, data summary and interpretation,
report preparation and review. Reviewing and approval of laboratory data, protocols and reports.
- Equipment qualification and Troubleshooting
- Seeking creative approaches to improve the accuracy, reliability, flexibility and productivity of the
department
- Improving analytical development processes in accordance with regulations and guidelines.
- Representing the department on cross-functional and external teams
- Leading and conducting Customer and Regulatory audits
- Quoting analytical projects (Analytical services buisness dev.)
- Management of the analytical development budget (Revenue and Resources)
- Products Specification (for New raw material and product introduction);
- Evaluation of Stability Trend;
- Constant Support on Customer decisions and proposals
- Laboratory Investigation using a 6M approach
- Support on:
- Management on New Project;
- QA Manufacturing Investigations;
- Product Development Reformulation; - Cleaning and Process Validations;
(June 2011 - Dec 2014)
Analytical Development Analyst & Stability F
Formazione
Perito Chimico
Galileo Galilei
set 1998 - giu 2002
Istituto tecnico industriale Statale indirizzo Chimico
Lingue
Inglese - Ottimo
Informazioni addizionali
Focal point
Good experience in project management groups. Kanban Lean Six Sigma. Excellent knowledge of ICH and GMP. I have participated in projects lean six sigma (Model 5S) of which are still Owner within the quality control laboratory.
Excellent knowledge and use of Qc Instrument
Good knowledge of Windows , the application of OFFICE (Word, Excel) AS400 system, LIMS and Agilent ChemStation, Empower 3, Trackwise, Minitab for statistical evaluation