Experience

Micro-Sphere SA

• Switzerland
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Unit Manager & Qualified Person

  • May 2015 - Present

  Micro-Sphere SA is a pharmaceutical Contract Development and Manufacturing Organization (CDMO) with specialist expertise in the spray drying of APIs and HPAPIs. The facility delivers both clinical and commercial scale spray drying and capsules filling services for pharmaceutical Companies across the globe.I am actually responsible for the Quality Unit, which comprises both Quality Assurance and Quality Control Departments and for the release, as Qualified Person for Switzerland, of the drug products batches manufactured and controlled at our facility.Main activities and responibilities:- Release of drug products batches- Customers and Regulatory Authorities Audit management- Customer management for all Quality-related matters- Quality and Technical Agreements- Sub-contractors and Suppliers selection and qualification- Management of all Quality-related processes (EBRs and analytical packages review, quality management for tech trasfer of Customers' processes, qualifications and validations review and approval, self-inspections, SOPs, training management, process validation, cleaning validation/verification programs, complaint management, deviations and non-conformities management, CAPAs, OOS/OOT/OOE, change management, APQRs, Site Master File and Plant VMP, Risk Assessments).

• Quality Assurance Manager

  • Apr 2008 - May 2015



IBSA sa

• Quality Assurance : Change Control Manager

  • Jul 2005 - Apr 2008

  Member of the Quality Assurance Staff, directly reporting to the Quality Assurance Director, I was employed as Change Control Manager, responsible to define, co-ordinate and maintain the change requests management process. Besides the core task, I have also been appointed as QA-supervisor responsible for granting quality oversight on the Installation, Operational and Performance Qualification documentation relevant to the main utilities and pieces of equipment installed in a new realised facility dedicated to soft-gel capsules manufacturing.



Pro. Bio. Sint. S.p.a.

• Italy
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Assurance Manager

  • 2003 - Jun 2005

  As Quality Assurance Manager, I was responsible to support the Technical Director in the management of all quality related processes (SOPs, deviations, non-conformities, OOS/OOT, APQR, change control, complaint management, Regulatory Authorities Audit management).

• Quality Control Assistant

  • 2001 - 2003

  Main activities and reponsibilities:- coordinating all stability programs- maintaining understanding of all applicable stability regulations- supporting Regulatory Audits on all matters relating to products stability

• Quality Control Supervisor

  • 1999 - 2001

  I was resopnsible to:- oversee physical/chemical testing and analyses of pharmaceutical raw materials and APIs- conduct laboratory investigations and drafting deviation reports as needed- oversee the periodical maintenance and calibration programs for the laboratory equipment

• Quality Control Analyst

  • 1996 - 1999

  API starting materials analyses, IPCs and finished APIs and HPAPIs analytical control