Marta Ugochukwu Monincova
MoCare Technologies
Consultant
CURRICULUM VITAE
Name: MARTA UGOCHUKWU MONINCOVÁ
Year of birth: 1978
Country: Czech Republic
EDUCATION
• ECA Academy GMP Auditor
• Course for Qualified Persons of Manufacturers of Medicinal Products
• Ph.D. Biochemistry – Biomolecular Chemistry
• MSc. General Biology - Microbiology
EXPERIENCE
Senior GMP Consultant – MoCare Technologies (CZ) – Jan. 2022 to present
• Consultation activities on GMP and Pharmaceutical Quality Systems
• Provide support and consultations for manufactures of drug substances and drug products (solid dosage forms, sterile and aseptics, biotechnology and vaccines)
• Develop and improve customer Pharmaceutical Quality System
• Develop and write key documents for Pharmaceutical Quality System – Site Master File, Quality Manual, Validation Master Plan
• Develop and write technical SOPs and similar documents
• Risk Assessments
• Trainings of personnel in pharmaceutical companies, workshops for pharmaceutical professionals and government bodies
• Design of environmental monitoring, clean media monitoring, sanitization and disinfection program
• GMP Audits
Senior GMP Consultant – G.M.PROJECT (CZ) – Sept.2011 to Jan.2022
• Consultation activities on GMP and Pharmaceutical Quality Systems
• Validation documentation (VMP, URS, DQ, cleaning validation, process validation, media-fill)
• Develop and writing of key documents and technical SOP´s relevant for GMP and pharmaceutical manufacturing
• Risk assessments
• Training, workshops (GMP, GDP, PQS, QRM, Qualification and Validation, API manufacturing, Technology Transfer, Toxicological Classification of APIs, Pharmaceutical Microbiology, Clean Media, Biological Evaluation of Medical Devices, Data Integrity, Clean Rooms, Aseptic Manufacturing, Sterilization Processes, Contamination and Cross-contamination control
Research Technician – Masaryk University (CZ) – 2002 - 2007
• Microbiology – fermentation and fermentation design and scale-ups, strain collection keeping
• Protein biochemistry – expression and purification of recombinant proteins
Molecular biology – cloning, PCR, sequencing, isolating DNA, electrophoresis, blotting
Name: MARTA UGOCHUKWU MONINCOVÁ
Year of birth: 1978
Country: Czech Republic
EDUCATION
• ECA Academy GMP Auditor
• Course for Qualified Persons of Manufacturers of Medicinal Products
• Ph.D. Biochemistry – Biomolecular Chemistry
• MSc. General Biology - Microbiology
EXPERIENCE
Senior GMP Consultant – MoCare Technologies (CZ) – Jan. 2022 to present
• Consultation activities on GMP and Pharmaceutical Quality Systems
• Provide support and consultations for manufactures of drug substances and drug products (solid dosage forms, sterile and aseptics, biotechnology and vaccines)
• Develop and improve customer Pharmaceutical Quality System
• Develop and write key documents for Pharmaceutical Quality System – Site Master File, Quality Manual, Validation Master Plan
• Develop and write technical SOPs and similar documents
• Risk Assessments
• Trainings of personnel in pharmaceutical companies, workshops for pharmaceutical professionals and government bodies
• Design of environmental monitoring, clean media monitoring, sanitization and disinfection program
• GMP Audits
Senior GMP Consultant – G.M.PROJECT (CZ) – Sept.2011 to Jan.2022
• Consultation activities on GMP and Pharmaceutical Quality Systems
• Validation documentation (VMP, URS, DQ, cleaning validation, process validation, media-fill)
• Develop and writing of key documents and technical SOP´s relevant for GMP and pharmaceutical manufacturing
• Risk assessments
• Training, workshops (GMP, GDP, PQS, QRM, Qualification and Validation, API manufacturing, Technology Transfer, Toxicological Classification of APIs, Pharmaceutical Microbiology, Clean Media, Biological Evaluation of Medical Devices, Data Integrity, Clean Rooms, Aseptic Manufacturing, Sterilization Processes, Contamination and Cross-contamination control
Research Technician – Masaryk University (CZ) – 2002 - 2007
• Microbiology – fermentation and fermentation design and scale-ups, strain collection keeping
• Protein biochemistry – expression and purification of recombinant proteins
Molecular biology – cloning, PCR, sequencing, isolating DNA, electrophoresis, blotting