Monia De Rocchis

Curriculum vitae Personal Information Name:​ ​ Monia; ​Surname​:​ De Rocchis; Nationality​:​ Italian; ​Marital status:​unmarried; ​Born in​:​ Ceccano (FR); ​on​:​ 16/03/1976; Living in:​ via Ferruccia n° 21, 03010 Patrica (FR); phone:​ -; ​Mobile phone:​-; e-mail:​- Education Graduation of secondary school focusing on sciences on June 1995 at Secondary school ”Francesco Severi” Peschieta 03023 Ceccano (FR)Italy Degree (five years-old order) in Chemical Engineering get:​ 18/07/2005; ​where: ​University of​ ​ Roma “La Sapienza”; Title of thesis: Analysis of critic transient state during the emergency stop of a production ammonia plant. Graduation to the course Law 494/96 art.10 get in Rome on 11July 2003 at University of Rome “La Sapienza” Graduation to the course of specialization “Installation-design of photovoltaic solar plant” get on 22 September 2007 in Rome. Graduation to the course “Clean Rooms: cleaning and simulation of aseptic process” get on 14 November 2007 in Menarini Biotech srl (Pomezia- Rome). Inscription at register for association engineer in Frosinone on 17 December 2007. Professional experiences March 2004-December 2004: development of thesis in Engineering Company Technip Italy S.p.A v.le Castello della Magliana,- Rome. Knowledge of the static and dynamic simulation using the software Aspen 12.1 di Aspentech. November 2005-April 2006: stage in pharmaceutical company Sanofi-Aventis, Group Lepetit of Anagni (Fr) Italy. May 2006​: starting work with a temporary contract and after with fixed contract in the same company. Role:​ Packaging Engineer in the Supply Chain area. - Management of standardization project for packaging of primary,secondary and tertiary for new and/or existing materials according to quality and Security to optimize the process(increase efficiency of the packaging line,reduction of the inventory,etc) - Management of technical drawings, specifics, Bill Of Materials (BOM) and operative instructions - Management of the master data of the primary/secondary packaging materials for packaging line/filling line - Management of the costs and coordination with the Production Department to execute qualifications trials and validation activities on the packaging materials for new products or validation activities due to modification of Packaging line. - Collaboration with Q. Assurance to perform technical agreement - Focal point for the quality aspects about the Supply Chain organization: area of material storage,SOP, transport, pre-audit. Professional experiences Role January 2007-August 2007:​ Supervisor of the Packaging Department: - Check batch record of the finished goods according to standard GMP. A​ssistent to the operators on the packaging lines according to GMP procedures. Role ​ A ​ ugust 2007-April 2008​: Quality Compliance: - Check the batch records for the finished goods. - Release of the manufacturing batches; management of the deviations related to the finished goods. Role (actually, since June 2008 ):​ Manufacturing Technologies Expert: -Project leader for the management of the activities related to the project,as follows: - -Transfer of a new product from another manufacturing site -Introduction of a new product from the research and for Clinical study -Coordination of the status and problems inside the Site and within the other involved functions - Focal point for the comunication with the industries and the Management within the transfer Management of the industrial transfer process and analysis in collaboration with the responsible person of the donor site. - Responsible for the writing of protocols/industrial reports and the working instructions concerning the production and the packaging activities on the base of the information received from the Donor. - Assistance to the industrial process in order to verify the correct execution of the operative instructions and the respect of the issued documents. - Assistance and coordination for the activities related to the validations activities, trial batches, trial on pilot plant and manufacturing batches full scale. - Validation activities on ​Oral Solid Department - Knowledge about sterile manufacturing process (liquid and lyo process) and solid products. Professional experiences Actual Position: - Member of a Team ​Jewel Project​ for the project and construction of new plant under isolator technology for the manufacturing of sterile lyo products. -Focal point for the introduction of Single Use System in the manufacturing operations. Information technology knowledge Microsoft Windows XP, Vista, Windows 7 Application: Office; internet / e-mail. ​Programming language:​ Aspen Plus 12.1; Aspen Dynamics 12.1 ​Use of SAP system to management the materials, BOM ,warehouse, industrial batches. Use of POMS to create Bill of Materials; Master Batch production Records Language English; Level Written/Spoken: Good/Good. Interests: Artistic cities; cinema; painting; dance; swimming; fitness. Driving licence Category: B. I authorize expressly my personal information for your necessity of selection and comunication, according to Law 196/2003. Frosinone, Italy, 11/07/2018 Monia De Rocchis