Nicola Manghisi
QA GMP & Validation Consultant at GS Consulting SrLs- Claim this Profile
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Italian Native or bilingual proficiency
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English Full professional proficiency
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Bio
Joseph Fosco
I highly recommend Nicola Manghisi for cGMP consulting projects, particularly for data integrity responsibilities. I worked with Nico on a very large and successful data integrity remediation project. Nicola is very competent, hard working and a team player. Using his bilingual talents, he went beyond his job description to assist other team members by interpreting and translating technical documents. He is a pleasure to work with and I would welcome the opportunity to work with Nico again.
Sandra Rincon
Worked with Nicola, was an excellent experience, he is a very professional, problem solver and excellent team player. He has a technical knowledge and a proactive vision of quality and his enthusiasm put him in a special category at the time to choose a person for a job. During my work with him, he always was friendly with a smile in his face, collaborative with everyone, with no restrictions. I just have for him accolades and my admiration for a wonderful human being. Sandra M Rincon
Joseph Fosco
I highly recommend Nicola Manghisi for cGMP consulting projects, particularly for data integrity responsibilities. I worked with Nico on a very large and successful data integrity remediation project. Nicola is very competent, hard working and a team player. Using his bilingual talents, he went beyond his job description to assist other team members by interpreting and translating technical documents. He is a pleasure to work with and I would welcome the opportunity to work with Nico again.
Sandra Rincon
Worked with Nicola, was an excellent experience, he is a very professional, problem solver and excellent team player. He has a technical knowledge and a proactive vision of quality and his enthusiasm put him in a special category at the time to choose a person for a job. During my work with him, he always was friendly with a smile in his face, collaborative with everyone, with no restrictions. I just have for him accolades and my admiration for a wonderful human being. Sandra M Rincon
Joseph Fosco
I highly recommend Nicola Manghisi for cGMP consulting projects, particularly for data integrity responsibilities. I worked with Nico on a very large and successful data integrity remediation project. Nicola is very competent, hard working and a team player. Using his bilingual talents, he went beyond his job description to assist other team members by interpreting and translating technical documents. He is a pleasure to work with and I would welcome the opportunity to work with Nico again.
Sandra Rincon
Worked with Nicola, was an excellent experience, he is a very professional, problem solver and excellent team player. He has a technical knowledge and a proactive vision of quality and his enthusiasm put him in a special category at the time to choose a person for a job. During my work with him, he always was friendly with a smile in his face, collaborative with everyone, with no restrictions. I just have for him accolades and my admiration for a wonderful human being. Sandra M Rincon
Joseph Fosco
I highly recommend Nicola Manghisi for cGMP consulting projects, particularly for data integrity responsibilities. I worked with Nico on a very large and successful data integrity remediation project. Nicola is very competent, hard working and a team player. Using his bilingual talents, he went beyond his job description to assist other team members by interpreting and translating technical documents. He is a pleasure to work with and I would welcome the opportunity to work with Nico again.
Sandra Rincon
Worked with Nicola, was an excellent experience, he is a very professional, problem solver and excellent team player. He has a technical knowledge and a proactive vision of quality and his enthusiasm put him in a special category at the time to choose a person for a job. During my work with him, he always was friendly with a smile in his face, collaborative with everyone, with no restrictions. I just have for him accolades and my admiration for a wonderful human being. Sandra M Rincon
Credentials
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Cert Prep: Word Associate - Microsoft Office Specialist for Office 2019 and Office 365
LinkedInMay, 2020- Nov, 2024 -
Cert Prep: PowerPoint 2016 Microsoft Office Specialist (77-729)
LinkedInApr, 2020- Nov, 2024 -
Cert Prep: PowerPoint Associate - Microsoft Office Specialist for Office 2019 and Office 365
LinkedInApr, 2020- Nov, 2024 -
Advanced Training Course in “QA & GMP COMPLIANCE”
Quality Assurance AcademyOct, 2019- Nov, 2024 -
Agreements for Success in Global Projects
LinkedInOct, 2019- Nov, 2024 -
Become a Six Sigma Black Belt
LinkedInSep, 2018- Nov, 2024 -
Change Management Foundations
LinkedInSep, 2018- Nov, 2024 -
Leading Productive Meetings
LinkedInSep, 2018- Nov, 2024 -
Lean Six Sigma Foundations
LinkedInSep, 2018- Nov, 2024 -
Learning Minitab
LinkedInSep, 2018- Nov, 2024 -
Operational Excellence Foundations
LinkedInSep, 2018- Nov, 2024 -
Process Improvement Foundations
LinkedInSep, 2018- Nov, 2024 -
Project Management Foundations: Communication
LinkedInSep, 2018- Nov, 2024 -
Project Management Foundations: Stakeholders
LinkedInSep, 2018- Nov, 2024 -
Project Management Foundations: Teams
LinkedInSep, 2018- Nov, 2024 -
Six Sigma: Black Belt
LinkedInSep, 2018- Nov, 2024 -
Six Sigma: Green Belt
LinkedInSep, 2018- Nov, 2024 -
Statistics Foundations: 1
LinkedInSep, 2018- Nov, 2024 -
Statistics Foundations: 2
LinkedInSep, 2018- Nov, 2024 -
Statistics Foundations: 3
LinkedInSep, 2018- Nov, 2024 -
Six Sigma Foundations
LinkedInAug, 2018- Nov, 2024 -
Excel Statistics Essential Training: 2
LinkedInJun, 2018- Nov, 2024 -
Excel Statistics Essential Training: 1
LinkedInMay, 2018- Nov, 2024 -
Practical Laboratories of Microbiology: Calculations, dilution, filtering and bioburden.
Eurofins BioPharma Product TestingMay, 2018- Nov, 2024 -
HPLC: Theoretical aspects and practical demonstration. Advanced Course for HPLC operators.
Eurofins BioPharma Product TestingApr, 2018- Nov, 2024 -
HPLC: theoretical aspects and practical demonstration. Basic course for HPLC operators.
Eurofins BioPharma Product TestingApr, 2018- Nov, 2024 -
Registration to the ONB (Ordine Nazionale dei Biologi)
Ordine Nazionale dei BiologiJun, 2008- Nov, 2024
Experience
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GS Consulting SrLs
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Italy
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Business Consulting and Services
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1 - 100 Employee
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QA GMP & Validation Consultant
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Nov 2019 - Present
GS Consulting, has been supporting the Pharmaceutical Industry with a growing portfolio of services since 2011. We are based in the Rome (Italy), providing services that connect Pharmaceutical companies throughout the regulatory environment of the EMA/FDA. Our clients include API manufacturers, a wide variety of finished dosage form manufacturers, CMOs, intermediate processors, testing facilities, medical device manufacturers, homeopathic and food ingredient suppliers. We can staff our projects with a combination of technicians to allow our clients the benefits of a cost-effective engagement, along with the best and most qualified consultants available for the particular task at hand. We provide expansive guidance and experience in different areas including: • Quality Systems services• Validation of computer, automated process systems and equipments • Commissioning and Qualification • Project management• Suppliers Audits/Due Diligence/Self-Inspections QA GMP & Validation Consultant working on the revision of Qualification documentations of the manufacturing equipments (IQ, OQ & PQ), preparation and review of VP and VMP, Risk Assessment reports, writing and updating of Analytical methods for QC labs, SOP, WI, APQR and Deviation Management.
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Quality pharmaceutical professional
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Oct 2015 - Dec 2019
Chartered Biologist with experience in Academic research, Microbiology (clinical and pharmaceutical), pharmaceutical QC & QA. Since October 2015 I've been working as a consultant with international agencies joining data integrity and gap remediation projects at several pharmaceutical firms in Italy. Chartered Biologist with experience in Academic research, Microbiology (clinical and pharmaceutical), pharmaceutical QC & QA. Since October 2015 I've been working as a consultant with international agencies joining data integrity and gap remediation projects at several pharmaceutical firms in Italy.
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Altran
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France
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Information Technology & Services
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700 & Above Employee
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QA Consultant
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Dec 2018 - Mar 2019
Altran ranks as the undisputed global leader in Engineering and R&D services (ER&D), following its acquisition of Aricent. The company offers clients an unmatched value proposition to address their transformation and innovation needs. Altran works alongside its clients, from initial concept through industrialization, to invent the products and services of tomorrow. For over 30 years, the company has provided expertise in aerospace, automotive, defence, energy, finance, life sciences, railway and telecommunications. The Aricent acquisition extends this leadership to semiconductors, digital experience and design innovation. Combined, Altran and Aricent generated revenues of €2.9 billion in 2017, with some 45,000 employees in more than 30 countries.Working at a pharmaceutical firm in Milan specialized in the manufacturing of injectable drugs, in different pharmaceutical forms: solutions and lyophilized, vials, ampoules and pre-filled syringesDetails of the assignment (DR & CAPA Management):As a member of the DR & CAPA Management Team, I’ve been working on performing all the steps in order to conduct the process deviations, as according to the pertaining procedure and tools for finding the root-cause of the deviations under investigations, in order to find the most proper and agreed corrective action- preventive action, in order to prevent an eventual reoccurrence. The work consists, also, of the gathering of all the data, documents affecting the investigations and, also, talking to and interviewing the people informed in order to best focus and identify the reason of the incident occurred.
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Validant
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United States
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Business Consulting and Services
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100 - 200 Employee
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QC Data Integrity Consultant
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Oct 2017 - Nov 2017
Validant provides quality, manufacturing, engineering, and regulatory compliance expertise to biotechnology, pharmaceutical and medical device companies.Validant is specialised on planning and management of Data Integrity projects, Remediation projects, Due-Diligence exercise, Validation, Engineering and Post Market Surveillance.Pfizer is one of the largest biopharmaceutical companies in the world, with revenues of almost $ 52.8 billion in 2016. It is present in 160 countries with over 96,000 employees. The range of its products consists of historical drugs in the cardiovascular, anti-infective, urological, oncology and pain and inflammation, to new molecules in the field of vaccines and biologicals , to large-scale pharmaceutical products (marketed in over 100 countries). The head office is in New York, but is present in 160 countries. Pfizer is present in Italy since 1955 with a turnover of over 1 billion euros and 3,000 employees in 2015. The Catania plant was realized in 1959. Recently, its role in the production of sterile even generic injectable drugs has been strengthened. Area of 200,000 square meters of which about 45,000 are covered, splitted into an area of pharmaceutical production for Man. Pharmaceutical forms: sterile injectables specialized in the production of first-line parenteral antibiotics for hospital, penicillin and non-penicillin. The site has always been particularly attentive to the conditions of safety at work and to the protection of the external environment (OHSAS 18001 and ISO 14001 certifications). Details of the assignment:• Preparation/revision of lab datasheets. Datasheet are forms to be prepared for all test methods of finished products, raw and packaging materials in order to improve the ALCOA requirements of the lab analytical documentation.• Revision of lab documentation relevant SOPs and pertaining documentations resulting from the introduction of the datasheet.
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Teva Active Pharmaceutical Ingredients
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Israel
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Pharmaceutical Manufacturing
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700 & Above Employee
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QC Freelancer
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May 2017 - Sep 2017
Teva-Tapi is an international supplier of active pharmaceutical ingredients (APIs); AIFA, EU-GMP, US-FDA, SFDA complaint and serves almost 1000 customers in more than 100 countries from more than 80 years. Headquartered in Israel near Tel Aviv, TAPI employs more than 5,000 professionals at 19 sites worldwide. Our state-of-the-art production facilities are located in Italy, Hungary, the Czech Republic, Croatia, Israel, India, China, Mexico, and the United States.Working as a freelancer with NonStop Recruitment. NonStop Recruitment is an award winning, rapidly expanding specialist recruitment company covering multiple sectors with offices across Europe and proven capability further afield. Since 2000, NonStop has revealed as a leading recruitment specialist in the pharmaceutical medical devices, technical, social care and digital industries. The commitment to finding solutions meeting both the clients’ and candidates’ needs is the main focus of the Company and is on the basis of the dedication that has been recognised by the industry as the Pharma Times Clinical and Scientific Recruiter of the year 2007, and finalists in 2008 and 2010. Recently has been accoladed with the “International Graduate Recruiter of the Year 2010” from the National Graduate Recruitment Awards.Details of the assignment:• Design and customisation of Analytical Sheets for QC Laboratories;• Writing and review of General Analytical Methods for QC-Labs (HPLC, Water Content, pH, Lal-Test, Sterility test, Total aerobic bacteria, yeasts and moulds count);• Writing and review of QC analytical and microbiological SOPs;• Writing and review of Stability Reports and Stability Risk Assessment;• Review of the QC-Lab investigations and execution of the affecting risk assessment;• CSV of excel spreadsheets in use at the QC Lab according to the current and pertaining Divisional Policies and GLPs.
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Validant
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United States
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Business Consulting and Services
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100 - 200 Employee
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MQA Communication Consulting Support/ADR Analytical Data Reviewer (SME)/ QA/QC Consultant
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Oct 2015 - Feb 2017
Validant provides quality, manufacturing, engineering, and regulatory compliance expertise to biotechnology, pharmaceutical and medical device companies.Validant is specialised on planning and management of Data Integrity projects, Remediation projects, Due Diligence exercise, Validation, Engineering and Post Market Surveillance.Details of the assignment:o Writing, review and translation of Client's SOPs for Manufacturing processes and for QC Labs for training purposes of the Validant SMEso Preparation of the training forms for the Validant MQA Protocol;o Collaboration with the Validant Dev. Management and Inv. Team in Prod. Env.;o Writing, review and translation of Investigation training to Client's Packaging Supervisor;o Training to 1 Client's Packaging Supervisor for managing and conducting Investigations in Prod. areas;o An. Data Rev. (Chemistry) activity for raw materials, finished and clinical products;o Management of the Validant Audit Trails documents for ensuring the release of the batches being reviewed according to the due dates;o Planning, management and organisation of ADR data packages archive according to the Validant requirements;o Retrieving of CoA and FdL through LIMS system for review purposes according to the procedures in forces;o Using of Trackwyse System for retrieving DR-Report and Ad-Hoc Reports for assessing the state of the Deviations involving the batches being reviewed;o Managing the Escalation Tracker spreadsheet for tracking the escalations raised during the review process and escalating them to the Client for putting action plans in place;o Managing and Reporting of the QC Metrics for Commercial and PDS (clinical) products, during the analytical review process, for highlighting the area of observations, for giving the Client an instrument for understanding the improvement areas at the QC Labs;o Provide Metrics reports as per the planned schedule for the QC organisation and associated projects.
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IFO - Istituto Nazionale Tumori Regina Elena - Istituto Dermatologico San Gallicano
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Italy
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Hospitals and Health Care
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400 - 500 Employee
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Biologist
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Jun 2013 - Sep 2015
The history of the IFO, a scientific institute and hospital for cancer research, began in 1926 within an old 18th-century hospital building called "St. Mary and St. Gallicano", located in Rome (Trastevere). As a result the "Royal Hospital Physiotherapy Institute of St. Mary and St. Gallicano" assumed the role of a study center for carrying out both physical therapy and research activities either in the treatment of the skin disease and the fight against cancer. In 1931, its original name changed to the "Royal Hospital Physiotherapy Institutes". The Regina Elena Institute (IRE) joined the San Gallicano Institute (ISG) for the Study and Treatment of Cancer on 21st April 1933. This arrangement defined the current organisation of IFO, and since then through IRE has played a key role in cancer research. The first Director of the IRE was the then President of the "Italian League in the Fight Against Cancer", Senator Raffaele Bastianelli.o Isolation of germs after seeding of biological samples (swabs, blood, faeces, semen.) into the culture media and reading of the plates after 24-48 hours for presumptive identification of germs;o Preparation and observation of slides from biological samples for microscopic examination;o Preparation and evaluation of microscopic and cultural examinations for Mycobacteria research.o Execution of RT-PCR for detecting Micobacterium tuberculosis and Clostridium difficile by means of GeneXpert system (Cepheid).o Planning of the subscriptions of the materials and the reagents.o Collaboration to the activities of the Healthcare-associated Infection Committee (HIC) for the management and control of healthcare-associated infections (monitoring and reporting of "alert organisms").o Collaboration in clinical research lines for the characterization of biofilm formation in bacteria and yeast.o Collaboration with the analytical reporting activities and the updating, writing and reviewing of the laboratory documentations and SOPs.
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Novartis
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Switzerland
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Pharmaceutical Manufacturing
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700 & Above Employee
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QC Stability Support
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Dec 2010 - Dec 2012
Novartis provides healthcare solutions that improve and extend people's lives. Novartis uses science-based innovation to address some of society's most challenging healthcare issues. Novartis discovers and develops breakthrough treatments and find new ways to deliver them to as many people as possible. The company is focused on industry-leading divisions with innovation power and global scale: pharmaceuticals, eye care and generic medicines.Novartis is headquartered in Basel, Switzerland. Novartis Group companies employ approximately 120,000 associates and its products are available in more than 180 countries around the world.Staff agency employee (Manpower)ManpowerGroup is the world leader in innovative workforce solutions, connecting human potential to the power of business. ManpowerGroup serves both large and small organizations across all industry sectors through our brands and offerings: ManpowerGroup Solutions, Experis, Manpower and Right Management.Details of the assignment:o Supporting the Stability sample and program management;o Configure and manage studies in LIMS;o Supporting the Stability data evaluation and trend analysis;o Supporting the Stability protocol and report generation;o Supporting the Stability time point check activity;o Collaborate in Laboratory Investigations (Management of the Laboratory Deviations, OOS and OOT in Sentry-Trackwise System);o Collaborate in the management of the QC Stability Archive;o Collaborate in alarm monitoring of the QC Stability and Sample Management equipment;o Support QC labs in planning the analytical activities in order to respect the established timelines;o Shipping of stability samples to be analysed from Novartis external site (Marburg site) and inclusion of results in LIMS and approval of the results, in accordance with the procedures in force;o Support QA for the activity of Data Review (Stability APR);o Support Project Management for submitting Stability Statements of NV&D vaccines;
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Sapienza Università di Roma
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Italy
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Research Services
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700 & Above Employee
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Scholarship holder
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May 2006 - Nov 2010
Sapienza University of Rome, founded in 1303 by Pope Boniface VIII, is one of the oldest universities in the world and a high performer among the largest universities in international rankings. Since its founding over 700 years ago, Sapienza has played an important role in Italian history and has been directly involved in key changes and developments in society, economics and politics. It has contributed to the development of Italian and European science and culture in all areas of knowledge. Sapienza enhances research by offering opportunities to academia on a global scale. Thanks to a special programme for visiting professors, many foreign researchers and lecturers periodically visit the University and contribute greatly to the quality of education and research programmes. Sapienza encourages international exchange: there are over 1,100 incoming and outgoing exchange students per year, thanks to several mobility programmes.1. Mentor for students about to graduate and earning the Bachelor's degree in Physical Chemistry;2. In charge to plan, execute and evaluate the experiments aimed to understand the self-assembly properties of the bile salt derivatives; 3. Contributor to submit and publish papers in different international physical-chemistry papers; 4. First author of one paper regarding the catanionic mixtures of bile salts derived nanotubes (Angewandte Chemie International Ed. Vol. 49, Issue 37; September 3, 2010 pages 6604-6607).
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Education
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2019 - 2019
QUALITY ASSURANCE ACADEMY
Advanced Training Course in “QA & GMP COMPLIANCE”, Pharmaceutical Sciences -
2008 - 2010
Sapienza Università di Roma
Second Level Master Course, Chemical Analysis & Quality Control -
2007 - 2007
Sapienza Università di Roma
State examination for admission to the ONB (Ordine Nazionale dei Biologi), 120/150 -
1997 - 2006
Sapienza Università di Roma
Master's Degree in Life Sciences, Biochemistry and Molecular Biology
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