Professional Profile:
Project Manager / Team Lead with extensive, diversified experience with multinational pharmaceutical companies. Quality Manager results-driven, motivated individual adept at designing and implementing comprehensive quality and training programs coupled with expertise in technical writing and abilities to plan implement projects, resolve issues, audit procedures/processes against site, corporate and regulatory requirements, interact positively with clients and ensure quality results in all work. I’m searching a position that fully capitalizes on this experience while providing further career growth.
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- 20 years of experience in biotech industry coordinating and managing operations, personnel, labs and Projects related Quality Unit (QA & QC) and the department efficiency
- Leader with motivational management style and reputation for building highly motivated and performing teams
- Qualified as international Lead Auditor for supplier (raw material, excipient, API) and CMOs
- Certified Black Belt and strongly oriented to the efficiency and value added processes
- Expert on asepsis pharma & biotech production, deviation, complaint, CAPA management, GMP – GDP – GLP Guidelines, Health Authorities inspection readiness (FDA, CFDA, Anvisa, EMA, KFDA, etc.)
- Result oriented achiever with very good abilities to address issues and leverage opportunities.
- Able to manage parallel and complex projects. Particularly brought to the management of staff and their professional growth.
Work Experience:
Head of Quality Consultants EMEA Region – freelance (Baxter International Ltd)
December 2017 to June 2019
- Responsible of Quality Business Process Assessment and related gap analysis for four EMEA plants. FDA inspection readiness.
- Responsible of Quality Business Intelligence looking to new IT Quality Tool implementation at regional level.
- Management of 4 consultants working on the roadmap for remediation quality plan on four EMEA plants.
- Sr. Business Analyst and Deployment Manager for the EMEA implementation of new Laboratory Information Management System – LIMS (BaxLIMS – LabVantage 8.3). Management of 16 project team members.
- Regional Training Responsible about LIMS usage and its GMP and data integrity compliance.
- Data Integrity and CSV expert.
- Interface between Manufacturing, Business Processes and Global IT dept.
Quality Unit Support Manager & Laboratories Manager (Merck Serono S.p.A.)
October 2007 to August 2017
- International Leader Auditor for qualification and periodic re-qualification of suppliers and CMO (Russia, Iran, Brazil, Turkey…) (GMP, GLP, GDP, GAMP, PICs, ISO 9001, ISO 13485, ISO TS 16949, ISO 11607, ISO 15378, ISO 18601).
- Laboratory resource management and supervision of all the analytical activities related to quality control of pharmaceutical packaging, excipient, API, finished and semi-finished products.
- Contributor in the deployment of QMS (ISO 9001:2015) and its sustainability, through internal SOP and periodical internal audit with the objective to assess the compliance of: data management, internal processes, customer satisfaction (complaint), improvement opportunities, risk evaluation.
- Internal expert and trainer on the Pharma GMP and Packaging world themes through structured meetings.
- Trainer for all efficiency techniques related to Lean Six Sigma, Kaizen methodologies (Certified Green Belt). Management of several projects to maintain the certification (European project on production losses, Global supplier selection, Laboratories Automation, Lead time reduction)
- Operational Excellence Project Manager with the focus to identify and define Quality Department KPI and related monitoring for Tier 2 and Tier 1 discussion and presentation.
- Expert and trainer at suppliers, third parties and CMOs on topics related to pharmaceutical production in asepsis, validation of manufacturing and/or packaging processes, basic rules for structuring quality control of raw materials and finished product, batch record template definition and control, CAPA & Complaint management, Data Integrity, CSV, Environmental monitoring for classified areas, analytical method implementation and validation at third parties’ laboratories.
- Design study and validation protocols definition, review and approve, on ISO and GAMP5 basis, for Medical Device testing and assembling, packaging changes or new packaging implementation.
- Strategic Planning for Quality Department (dept roadmap), management of multisite international efficiency projects.
- Root Cause investigator for Customer Complaint.
- Experience in Risk Management.
- Team member of CSV activity and Project Manager for Data Integrity Guidelines alignment.
- Backroom Responsible for International Health Authorities Inspection (AIFA, Anvisa, EMA, FDA, CFDA, etc etc)
- Quality Department Budget preparation (head count, capex, opex, projects)
- Personnel Selection for Quality Unit Department (Labs. Technician, QA Specialist, Coordinator)
- Study and Departmental Alignment to International Guidelines, GMP and Pharmacopoeias (USP, Ph. Eur, JP Ph.)
- Management of retain and reserve samples.
- SAP QM Business Architect and Project Manager for Italian plants deployment.
- LIMS Key User (Labvantage 8.2)
- SAP/LIMS interface Project Manager
- Responsible for Sampling Area activities (sampling raw materials, API, excipient)
- Preparation of standard or operating procedures for incoming control of primary packaging materials (direct contact with the drug), secondary (end user packaging), medical device, excipient and API.
- Multi-year experience in the physical chemistry laboratory of the same company.
Chemical Laboratory Specialist & Coordinator (Merck Serono S.p.A.)
September 2003 to October 2007
▪ Laboratory Senior Technician with coordinating function on 20 technicians. Definition and monitoring of daily task and weekly objective focused on no business interruption.
▪ Specialist of analysis on API, excipient, primary packaging, semifinished product, utilities (gas & water)
▪ Deeply knowledge of elementary chemical lab equipment: pHmeter, Osmometer, Coulometer, Conductometer, Melting Point, TOC etc.
▪ Deeply knowledge of complex chemical lab equipment: HPLC, UPLC, NIR, Polarimeter, Raman, GC, Spectrophotometer UV-VIS.
▪ Project Manager related to Lab. Automation activities.
▪ Writer of analytical lab procedure, protocol and validation report. (OQ, PQ).
▪ Management of deviation report, analytical investigation and Root Cause Analysis.
Packaging Laboratory Specialist & Coordinator (Merck Serono S.p.A.)
October 1997 to September 2003
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- Laboratory Senior Technician with coordinating function of 10 technicians. Definition and monitoring of daily task and weekly objective focused on no business interruption.
- Sampling of primary and secondary packaging materials
- Sampling of API and excipient in a classified area (Sampling Area)
- Visual and Dimensional testing on packaging material and medical device components
- Deeply knowledge of packaging lab equipment: dynamometers, calipers, micrometer, profilometer, optical meters and proof-reader.
- Project Manager related to Lab. Automation activities.
Education
June 2010 – December 2015
| University of Milan Bicocca:
High School Ettore Maiorana (Bari): |
Master’s Degree Science and Technology of Materials (110/110)
Facing the course of university studies, in conjunction with the pursuit of the work, (theory applied to the practice of daily job), I’m able to provide specific training on: Organic Chemistry, Materials Structure, Solid State Physics.
Diploma as Biological Chemistry Laboratory Technician Diploma as Food Biotechnologist (specialization of winemaking processes) |
| Communication skills | Excellent communication skills acquired in the context of the workplace and not only. Refined with international auditor and Project Manager experience, and also during the management of international health authorities’ inspections. |
| Organizational and Management skills | Strong organizational attitudes, matured in day-to-day management of a team of 31 people who need just-in-time planning or up to 1 week time horizon. Leadership also recognized within the Quality Unit department (80 people) as facilitator and organizer of project, training, event, team building. First point of contact for 250 end user as SAP – QM Global Key User. |
| Professional and IT skills | Extensive knowledge of production processes and qualitative requirements of the pharmaceutical, food, GDO and manufacturing sectors. Extensive knowledge gained in the activity of supplier leader auditor.
Deep knowledge of ERP system: SAP, Oracle, AS400. Excellent knowledge of: TrackWise, Discoverant, LIMS LabVantage, Outlook, Lotus Notes, MS Project, MS Office |
Additional Information
Certification: Green Belt and Black Belt
Languages: English (fluent)
Italian (native)
Hobbies: Fishing, Deejay.
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