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CV Profile No.93220

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Last name : *****************
First name : ***
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Email : ******@******
Date of birth : ********
Nationality : ***********
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Profile details

Job category searched
» Production, maintenance, quality
» R&D, project management
» Chemistry, petrochemistry, raw materials, mining
» Pharmaceutical industry
» Research and development
Professional experience . More than 10 years
Professional Experience: 
Director
CMC-GMP
Since 12.2020
Pharmaceutical Consultant and Project Management Agency
Head of Research and Development
WIldlife Pharmaceuticals
03.2017 - 11.2020
• Operations management of the chemical plant • Quality assurance matters of the chemical plant • Synthetic chemical research • Chemical process research • Finished pharmaceutical product dossier development • Active pharmaceutical ingredient master file development • General management • Budgeting • Synthetic development and analysis • Product and process development • Budgeting and business strategy • Clinical evaluation of developmental products • Project management and leadership • Chair of the animal ethics committee • Fine chemical production • Pharmaceutical product development • Management • Auditing of suppliers
Skills
Chemistry: manufacturing of active pharmaceutical ingredient starting materials, origination of compound and complex material safety data sheets, origination of compound and complex certificate of analysis, raw material developmental, pilot and production runs, active pharmaceutical ingredient development, pilot and production runs, API manufacturing. ICH guidelines: Good laboratory practice (GLP), Origination of master production instructions, Active Pharmaceutical Ingredient Master File, Chemistry Manufacturing and Controls. Quality: QMS, Document management, Quality control, Quality assurance. Finished pharmaceutical product: Pharmaceutical product formulation, pharmaceutical product development, pharmaceutical product clinical evaluation. Good Manufacturing Practice (GMP): Manufacturing of sterile liquid injectables, sterile process development, sterile facility design, current good manufacturing practice, GMP auditing, origination of batch manufacturing records. Regulatory: SAHPRA Act 101 sterile liquid injectables, PICS, FDA, Pharmaceutical product dossier, CTD, Regulatory Affairs. Clinical Animal Research: Animal Ethics, research proposals, animal trial coordination, animal trial execution Operational: Budgeting, production planning, project management, warehousing, business strategy, KPI’s.
Education . Doctorate
PhD Chemistry
University of the Free State
01.2005 - 12.2008
Languages
afrikaansnative
englishnative
More information
immediately
Gauteng
Johannesburg
Permanent contract - Fixed-term contract - Temporary work - Internship - Cooperative Education Program - Part-time work
01.08.2021
59

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