Isabel Lemos Email and Phone Number

Qualified Person and responsible for the implementation of the Quality System in the new plant to produce Herbal Medicinal Products starting up in Portugal, including setting up QC laboratory and Quality Control and Quality Assurance team.Designing and setting up the Quality Management System to support GMP activities.

As trainer in GMP and Analytical Methods Validation in Post Graduation Master in Pharmaceutical Industry

Consultant for Quality Control Organization and Quality Assurance Services in Chemical and Pharmaceutical Industry.

Working since 2015 for Janssen Pharmaceuticals in the elaboration of Criticality Analysis Reports for Janssen medicines and active pharmaceutical ingredients manufactured at Janssen plants.

Qualified Person for Wholesale Distribution

Quality Control and Quality Assurance Manager.• Responsible for the planning and coordination of the analytical work including analyses of raw materials, intermediate product, finished products, stability studies and analytical development and validation. • Responsible for the management of certifications ISO 9001:2000, ISO 13485:2004, ISO 14001:2004 and OHSAS 18001:1999) between 2004 and July 2010.• Responsible for the Implementation of a Quality Assurance System: Internal and External Audits, Qualification Protocols and Reports Approval (equipment, cleaning validation, process validation), Deviations Control, Change Control System, CAPA System, OOS Control, Complaints System, Calibration Plan, Annual Product Review, Site Master File Update, Risk Management and Supplier Qualification.

Responsible for the planning and coordination of the analytical work including analyses of raw materials, intermediate product, finished products and Stability Studies.

Head of Section at Chemical Laboratory of The Quality Assurance Department - Labor Qualitas - Estudos e Controle na Qualidade S.A., - Grupo Tecnimede. GLP Study Director of the Pharmaceutical Development Department - Labor Qualitas – Estudos e Controle na Qualidade S.A.

Sept 1989/Apr. 1990: Assistant at Microbiology Laboratory - Hovione Sociedade Química S.A.May 1990/Oct. 1992: Assistant at Chromatography Laboratory - Hovione Sociedade Química S.A. Nov. 1992/Feb. 1998: Head of Section at Basic and Instrumental Analysis Laboratory - Hovione Sociedade Química S.A.