25 years of experience in GMP (batch release, quality management, auditing, regulatory affairs, production, quality control) and GDP environment (distribution, cold chain, temperature mapping, quality management)M.Sc. degree Industrial Pharmaceutical Sciences, School of Pharmacy, University of ManchesterEligible Qualified Person (QP) for batch release according to EU regulationsStrong verbal and written communication skills; well-developed teamwork and collaboration skillsIn-depth knowledge/experience in areas of current GMP and GDP regulations, pharmaceutical manufacture, quality control and batch releaseExcellent knowledge of the following quality management standards: ISO 9001:2015, ISO 13485: 2016, ISO 22716:2007 and ISO 15378:2017Great auditing experience with 150+ executed GMP, GDP and quality system audits Significant batch release experience (QP role) – sterile products, solid oral forms, semisolids, non-sterile solutions, including the batches manufactured and/or tested by contract manufacturer/laboratoryStrong background in principles, science, and regulatory aspects of the sterile/aseptic production, solid oral forms production, pharmaceutical water systems, cold chain, qualification and validation, CAPA management, change management, risk management and computerized systemsMain areas of expertise:Good Manufacturing PracticeGood Distribution PracticeGMP/GDP AuditingGMP/GDP TrainingAseptic processingSterile manufactureRisk managementDeviations Management and CAPACold chainQP role and batch release