Analía Acebal Email & Phone Number

Argentina

Argentina

Biotech and Pharma CMC advisor

Argentina

Argentina

Argentina

Quality Assurance, Quality Control and ValidationDeputy Head Pharmacist - Regulatory Affairs

Argentina

33 people.Quality Control and Quality Assurance respobsibilities.QC

Canadá

Process Industrialization leader for a new Vaccines Bulk manufacturing building project - Toronto site, Canada.# Process scale up# Process, equipment and technology definition (URS, PS, DS). PFDs, and PI&Ds support.# Qualification activities (FAT, SAT, IQ, OQ - Commissioning)# Technology Transfer# Process Characterization and Robustness# Process Validation life cycle (strategy, documentation and execution)# Cleaning Validation# Characterization and Stability strategies# Support to Regulatory department for product submission# Strong communication skills, team working with QO, Engineering Industrial technology and Manufacturing team.# Human resources, budget, investment, and planning management.# Respect of project timelines and objectives following best Manufacturing technology and Engineering Best Practices

 Strategy definition and implementation of Clearnng and Process Validation.Process Follow up and Production SupportTo maintain Process Know HowProcess Standardization and Improvemento Process analysis / Improvement proposalso To define trials and Experimental Planso Yield Improvemento Improvements implementation in Production scaleDocumentation Activities o SOPs /Validation Plans/ Protocols / Reportso Failure Investigations and Change Controls o Process Documentation (Process Mapping, Parameter and Attributes Risk analysis)Site Seed Manager: Responsible for Seeds lots production, storage and stock.

 Activities related to Biotechnology Processes production management (production planning, resources organization, production implementation). Batch Records review and approval.  Identification of trends, problems or improvements by Process results follows up. Manufacturing Technology support on trials development, implementation and result analysis.  cGMP SOPs definition, implementation and follow up. Inspection and audits reception. New process line implementation responsible. Improvement production capacity evaluation. Human resources, budget, investments, objectives and plans management. Quality system builds up and maintenance within production scope.

Activities involved in Validation Master Plan, development, implementation and management for a new Bitechnology site of sanofi pasteuro Process and Cleaning Validationo HVAC, Utilities, and Facilities cGMP compliance reviewo HVAC, Utilities, Facilities, Process equipment, Automatic Control Systems and Software commissioning, qualification and Validation.o Quality Assurance tools development and handling (change control, deviations, etc)

Cardinal Health Argentina Validation Master Plan design, implementation and management of related activities. Process Validation / Cleaning Validation / Validation of Analytical Methods for residues / Software validation / Equipment, Services and Facilities Qualification / Instrument Calibration / Writing, revision and approval of areas SOP Managerial activities (resources management, budget and investment definition, new projects evaluation, etc).

Hoechst Marion RousselRaw Materials, sampling and analysis.Development Lab Equipment Operation SOP.Development of raw material methods of analysis.

Byk Liprandi Galenic Development Technician Testing Manufacture Methods / Testing of New Formula in novel developed products / Scaling Up of new products.Quality Control AnalystRaw Materials, intermediate products, and finished product analysis.Stability analysis and related analytical techniques development.

03/93 – 03/94 / Quality Control Lab. Raw Materials, intermediate products, and finished product analysis.03/94 – 06/94 / Analytical Development Stability analysis and related analytical techniques development07/94 – 09/94 / MicrobiologyMicrobiological Controls of Raw Materials, intermediate and finished products / Vitamins and Antibiotics, Microbiological Assay / Sterility Test 10/94 – 12/94 / Production Area Training in manufacture processSolids: granulation, compress and film coating (aqueous and organic phase) / Semisolid formulations: paste and cream / Liquids: solution and injection products (sterile products).

Diplomatura, Bionegocios

Finanzas Para No Financieros, Business Administration And Management, General

Gestión Estratégica, Business Administration And Management, General

Pdd, Business Administration And Management, General

Project Management

Farmaceutica, Farmacia

Tecnica, Quimica