Pharma & Biotech

Operational Quality Assurance
• Processing Quality Events / NC / CAPA / Change Control
• Coordinating quality action plans
• Quality management with suppliers, production and laboratories

Quality Management System
• Creating and reviewing the QMS according to the BPF/GMP
• Preparing audits and managing post-audit answers
• Training, awareness and supporting staff in the quality process

Validation of Computerized Systems
• Validation of computerized systems (GAMP5 environment, 21CFR part11)
• ERP, GED, automated and embedded systems
• Integration, software, unit and non-regression tests
• Data Integrity Projects (traceability, access, audit trail)
• VMP, protocols, tests and reports

Validation of Automated Systems
• Production and Laboratory Systems (PLC, IHM) and SCADA Supervision
• Audit trail, access management, data saving, back-up, restore
• VMP, protocols, tests and reports

Qualification of Equipments
• Equipment risk analysis // AMDEC – PFMEA
• Strategy of qualification
• VMP
• CQ, IQ, OQ, PQ
• Protocols, tests and reports
• Tests execution
• Non-conformities management

Process Validation
• Process risk analysis
• Worst cases
• Identification of CPP and CQA
• Risk strategy
• Protocols, tests and reports
• Tests execution
• Non-conformities management

Regulatory Affairs
• Marketing authorization applications (MAA) files
• Modules 2, 3, 4 and 5 (CTD and e-CTD format)
• Responses to health authorities of different countries

Pharmacovigilance & Clinic
• Management of adverse events, adverse reaction (AR) reports
• Writing PV reports (PSURs)
• Product benefit/risk management

Quality Control
• Analytical and microbiological development and validation
• Analysis of test results, management of OOS
• Data integrity project, LIMS installation

Industrial Transfer
• Management of inter- and intra-site transfers (complete lines or equipment relocation)
• Scale up, scale down
• Analytical transfer, technological transfer

Commissioning & Engineering
• User needs, drafting the requirements specifications, defining the specifications
• Purchase and installation of equipment, automated systems, utilities, premises
• Suppliers, installation and testing management