Experience

Cilag GmbH International

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Scientist

  • Feb 2014 - Present

  - Cleaning validation expert for solid and parenterals production areas;- Cleaning validation owner on the shop floor;- Qualified sampler for TOC, Swab, Rinse and Rodac sampling;- Validation Document editor for cleaning validation protocol/report, cleaning assessment, and cleaning procedure;- Project manager NPI for solid formulations - Cleaning validation expert for solid and parenterals production areas;- Cleaning validation owner on the shop floor;- Qualified sampler for TOC, Swab, Rinse and Rodac sampling;- Validation Document editor for cleaning validation protocol/report, cleaning assessment, and cleaning procedure;- Project manager NPI for solid formulations



Janssen Cilag Spa Via Janssen Latina

• Operation quality staff and scientific process support

  • Aug 2012 - Dec 2013

  - SOP (Standard operating procedure) / WI (Work instruction) / MBR (Master batch record) editor and reviewer;- Documentation readiness owner in preparation of HA inspections (AIFA, FDA, KFDA, ANVISA, Japan, Kenia, Turkish HA, Saudi Arabia);- Owner of investigation,event and CAPA in TrackWise;- BRR (Batch record reviewer) in SAP Europe2;- Document coordinator in DocSpace;- Involved in various business projects such as: software implementation for document management (DocSpace); software implementation for integration of production equipment and manufacturing processes on the automation network (Automation Layer).

• Cleaning and process validation staff

  • Aug 2010 - Jul 2012

  - Process validation owner on the shop floor of RX and OTC Pharma such as: Edurant (FCT); Incivo (FCT); Intelence (Tablets); Tylenol Cold Severe (FCT); Tylenol Sinus Severe (FCT); Sudafed PE Cold & Cought (FCT); Sudafed PE Triple Action (FCT); Benadryl Allergy Ultratab (FCT); Sibelium (CPS);- Packaging validation owner on the shop floor of RX and OTC Pharma such as: Perdolan Mono (T in blister); Intelence (Tablets in bottle); Tylex (CPS in blister); Concerta (FCT in bottle);- Process validation phase owner on the shop floor: mixing, encapsulation, wet and dry granulation, compaction, compression, coating, bottles and blister filling;- Cleaning validation owner on the shop floor;- MBR (master batch record) editor;- Validation Document editor for: process characterization protocol/report; process validation protocol/report; cleaning validation protocol/report; packaging validation protocol/report; stability protocol/report; registration protocol/report; shipping protocol/report; holding time protocol/report.



Farmacia Dott.ssa Cocozza Rosalba Frazione Domo (AN)

• Apprenticeship in pharmacy

  • Jan 2009 - Jul 2009

  Training about: professional and ethical behaviour of pharmacist, pharmacy administration, correct use of drug for patients, correct storage of drugs. Training about: professional and ethical behaviour of pharmacist, pharmacy administration, correct use of drug for patients, correct storage of drugs.