- QA Operations / QA Technology Operations- Bio-Pharmaceuticals / Biotechnology Products- Contract or External Manufacturing Oversight (Bio-Processing / Aseptic filling)- Good Distribution Practice / Transport Systems Validation or Performance Qualification- Clinical Supplies / IMPs

- Establishing and maintaining of QS for sponsor of clinical trials (GxP)- Qualification Audits of Contractors (GMP / GDP -Area)- QAAgreements Project Management- Proposals/Contracts/Pricing / - API (Recombinant Proteins) Manufacturing- Validation of Analytical Methods / Virus Reduction Studies- Tranport/Cold ChainQA for IMPs Production- Deviations Handling / Investigations / Failures- Quality Risk Management Systems- Change Controls… Show more - Establishing and maintaining of QS for sponsor of clinical trials (GxP)- Qualification Audits of Contractors (GMP / GDP -Area)- QAAgreements Project Management- Proposals/Contracts/Pricing / - API (Recombinant Proteins) Manufacturing- Validation of Analytical Methods / Virus Reduction Studies- Tranport/Cold ChainQA for IMPs Production- Deviations Handling / Investigations / Failures- Quality Risk Management Systems- Change Controls Handling- OOS Handling- Batch Record review- Creation and review of SOPs within QS Show less

- Quality Assurance in API Production- Handling of Deviations / Failed Run Investigations / Out of Specification Results /Change Controls - Process, Technical, Documentation- Batch Production Records Review- Review of relevant issues and preparation of documents prior batch release- Participation on creation and review of SOPs- QA customer service for API/GMP Projects- Qualification of suppliers within QS system- Creation of raw materials/consumables specifications

Researcher in field of molecular biology and genetics.Lab methods supervisor: PCR, Real-Time PCR, Sequencing of DNA, Electrophoresis, Protein analysis, DNA purification.Preparation of workshops for students. Participating in International conferences with ongoing projetcts.