Chemical Regulatory Consultant (REACH, CLP, environment & safety)Excellent knowledge of both REACH Regulation (EC) No.1907/2006, and CLP Regulation (EC) n.1272/2008 and subsequent updates.Complete consultancy for chemical substances, mixtures and articles, including full REACH registration, restrictions on use and exemptions and CLP notification of substances. Consultancy reports for regulatory and inspection bodies (i.e. MinSAL, ATS, ARPA, etc.)

Chemical Regulatory Consultant (REACH, CLP, environment & safety)Complete consultancy for chemical substances, mixtures and articles, checking for the presence of SVHC and restrictions on use.Coordination of a working group for the registration of substances under REACH (manage SIEF / Consortia and contacts with ECHA) and notification of substances, according to the CLP regulation.Teaching at universities, training in private companies; speaker at scientific meetings and conferences under REACH and CLP.

Responsible for both Quality System and validation activities; SOP issue and personnel training; management of foreign customer requirements, according to the company’s standard

Administration of automated packaging, production and utility systems; full system qualification, from requirement phase to system release; change control activities; SOP issue and personnel training

Good knowledge of the GAMP (Good Automated Manufacturing Practice) methodology for the automated system validation, in accordance with the european guidelinesGood knowledge of the FDA 21 CFR Part 11 rule ; practical application with an assessment procedure ; full management of the suppliers for the update of the not consistent systems ;Quality and automation supplier audits;Member of the team for new and legacy system validation ;SOP issue and personnel training about validation matters ;Good knowledge of the GMP rules (continuous refresher trainings);Partecipation to technical and management trainings

Good knowledge of production techniques on a large scale of sterile pharma drugs (opthalmics) ; utilization of complex systems within contamination controlled environments (ISO class 2-4) ;Analysis of problematics related to microbial contamination during aseptic productions ;Direct management of the production personnel (operators);Application of the GMP rules, in accordance with the FDA requirements ;SOP issue and personnel training about production matters ;Member of the atypical investigation team for the opthalmic department;Use of a custom automated system for the material handling

Use of multiple analytical techniques (spettrophotometry, gas cromatography, HPLC) for the execution of analysis on food matrices Management of analysis certificates