Experience

Doppel Farmaceutici

• Italy
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• • Jan 2017 - Present

  Coordination of technology transfer projects, from scale-up through manufacturing process optimization to registration and launch, both for oral and high potent compounds.Preparation and review of regulatory documents, compliance to product lifecycle management.Definition of objectives and methods for the implementation of TT projects by ensuring adequate budget and resources.Preparation of the key documentation fo TT (TT plan, gap analysis, TT report, project timeline)Supervision of the department activities for the correct execution of technical lots operations.Drawing up the MBR and MRP0 of technical and validation batches.Collaboration with the QC for Holding Time studies.Agree with customers to open Change Control (CC) relating to TT’s activities. Show less

• • Dec 2014 - Dec 2016

  Feasibility study and implementation of new projects on the production plants in close contact with customers and with the company departments listed below: Regulatory, Pharmaceutical Technology, Production, Engineering and Safety, Quality Control and Quality Assurance.

• • Jan 2013 - Nov 2014

  Management of the daily production scheduling.Customer order entry.Study of the feasibility of production orders with the verification of raw and packaging materials needs.Inclusion on the management system of product lists (both of the manufacturing and packaging phases) and consequent management of the approval and archive phases.Study of the "lead times" of the products according to the real delivery times of raw materials and packaging materials.

• • Jul 2003 - Dec 2012

  Feasibility study and industrialization of new products in collaboration with the pharmaceutical engineering department and customers.First drafting and subsequent revisions of the processing protocols (manufacturing, primary and secondary packaging) of the pharmaceutical forms (semi-solid, solid, oral liquids, suppositories, soft capsules) and of all the semi-finished products produced.Drafting of SOPs (standard operating procedures) of use, cleaning of machines and rooms.Compilation and related development of Change Control documentation concerning the production departments.Controlled management of documents relating to production equipment and machines (machine and room log book, scales calibration cards, etc.). Show less



Chiesi Group

• Italy
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Outsourcing department

  • Apr 2002 - Apr 2003