George Peletis

Background

About George Peletis

QA and QC Responsible, Oslo University Hospital • Responsible for quality monitoring of production processes, approval of specifications, test methods, and consumables for use in production and aphaeresis • Training of colleagues in consumable management, creation of training programs and SOPs, contributing to continuous improvement of SOPs (e.g. instruments, methods, and quality system documentation) • Creation and management of quality documentation for instruments and processes: Deviations (also as deputy for my leader), Risk Assessments, Change Controls, Verifications, Validations, Supplier Re/qualification, signing and archiving • Ensuring qualification, maintenance, and documentation of facility instruments, equipment, and service performed, escorting and assisting service engineers in cleanrooms as necessary, LIMS release of instruments for use, in close collaboration with the operations responsible • Responsible for microbiological control and trending results monitoring. One-on-one meetings with subcontractors relating to the improvement and verification of the facility’s cleaning program. Approved observer and sampler for clothing control • Joint responsible for performing internal and external audits, and assisting with facility audits from authorities (DMP) • Project-related quality support for pre-GMP (in-house lab) to GMP (facility cleanrooms) transition and manufacturing for clinical trials QC Analyst, Palla Pharma Norway: • Strict adherence to cGMP/GxP. Daily routine experience in ICH guidelines, analytical methodologies, and Eudralex regulations • Techniques: Dissolution and disintegration profiles of pharmaceuticals, Karl-Fischer water determination, titrations, Polarimetry, Relative Density, Refractive Index, Particle Size Distribution, Tapped Density, HPLC, GC, TLC, FT-IR, NIR, other tests • Hands-on experience in method validation and verification, writing of relevant reports and protocols, as well as Standard Operation Procedures and Specifications in accordance with internal and pharmacopoeian guidelines • Experience in documenting and reporting OOS (out-of-specification) and OOT (out-of-trend) results, and deviation management MSc work: • Synthetic and analytical methodology development, synthesis of bioactive compounds as potential clinical candidates • Purification of organic compounds (HPLC, GC, recrystallization, TLC, distillation, extraction, sublimation) • Proficient in NMR and structure elucidation through a variety of spectroscopic techniques (NMR, MS, IR, UV)