Senior Consultant und Industrieexperte

Quality / QA / QC / Pharma / Medical Devices / Chemistry: o construction and installation Quality Corporate / QA / QC site organizations o accountable QMS (i.a. implementation, set-ups, reviews, ICH Q10, ISO 9001/13485, 21 CFR Part 820, MDR, EFQM/ TQM, ISO 14001, Q standards, compliance, maintenance, SOP management/harmonization, DCM/eDMS, integrated systems/IMS, process/SIPOC management, QCP, process owner, KPI/KQIs/CIP, internal and external / supplier auditing, MDSAP, etc.) o responsible Quality / cGxP requirements and quality management (i.a. QA oversight, CMO management, lead GQRB/QRB, batch releases, cGMP/GDP, FDA/EU guidelines, SMF, quality by design, CMC, OCM, CHC, assessments/ GAP analyses, escalation/recall management, QA production/packaging, etc.) o inspection readiness programs (i.a. inspections FDA/EMA/Swissmedic/ANVISA/ CFDA/SFKN/KFDA/regional authorities, QSIT, remediation, PAI, MDSAP, etc.) o qualification & validation (i.a. VPM URS, DQ-PQ(I/II), SAT, TAT, FAT, Q review, pharma technique, plants/equipments, utilities, facilities, liophylisator, HVAC, WBI/WFI, processes, mediafill, (process) validation, sterilization, PCD, etc.) o quality assurance (i.a. release business, MSO, process validation, VDM, PQR/AQR, PDRs, complaint/deviation/CAPA/recall management, CC, data matrices/data integrity, supplier qualification, CMO business, QAA/QSV, PV, etc.) o transfer and transaction business (i.a. local/site to site/Swiss/EU/US/SA/Asia market, all transfer phases, carve outs, evaluation, project management, project design, operationalization, closes, i.a. entity, sites, plants, products/ lines, production/operations, equipments, HAVC, management, systems, processes, R&D/analytics/methods, packaging, track&trace, serialization, etc.) o risk management (i.a. site risk assessments, incident management, FDA risk based approach, risk strategy, GAP analyses, FMEA/HACCP, risk control, risk audit systems, ICH Q9, ISO 14971, etc.) o clinical studies and regulatory affairs (i.a. CMC, GCP, study phases I-IV, CDMR, REACH, regulatory strategy/management, etc.) o trainings (i.a. concepts/programs, management training, workshops, etc.). Production / Operations / EHS / Pharma / Medical Devices / Chemistry: o construction and installation Operations / Production and EHS organizations o operation/production (i.a. construction production, qualification runs, operational supervising, production/ corporate standards and performance, KPIs/Right-First-Time/PAS-X/EBR/OEE, delivery/cost/inventory/test reduction, etc., lead operating resources/personnel/products on schedule, upstream/downstream processes, PPS, SCM, engineering, MS&T, processing of raw materials, aseptic/steril production, IPC/visual inspection, Knapp qualification, defect data bank, GMP/QMS/ inspection readiness and compliance, cleaning rooms A-E, liquida / API (i.a. Fill & Finish), solida / API (i.a. granulation, extraction, wheiging, mixing, coating), fermentation, conti/ batch systems, stirrer tanks, containment, packaging, logistic/ distribution processes, Bio conversion, Bio katalyses, isolators, trainings, reporting, etc.) o strategy & performance management (i.a. production/product strategy/ production plants, digitalization/industry 4.0/MES, legal safety organization, awarness/mindset programs, team-building, SCM/sourcing strategy, B2B/B2C/ CMO business, R&D and portfolio programs, bring in the market/spin offs/new dosage forms, buy-in/out, lean/shop floor management and production, Best in Class/BPE/excellence programs, Six Sigma, change management, MCRS/ Reporting, due dilligence, turnarounds, SWOT/5-box analyses, road maps, etc.) o EHS management (i.a. responsible EHS management system, EMAS/ISO 14001/ etc., EHS Road Map /KPIs, site EHS and safety management, incident and emergency management, EHS trainings, EHS audits and (self) inspections, Compliance/GAP analyses, REACH, EHS risk management, reporting, etc.) o supply chain management (i.a. SCM/SCOR/SSCM, Sourcing - single/multi, procurement, life cycle, supplier/vendor management, etc.) o trainings (i.a. concepts/programs, management training, workshops, etc.). IT / IT QA: o MS office, MS project, SAP (since 2009), ERP (since 2010), Office (since 1998), LIMS since 2011), e-learning (since 2012), PMO tools (since 2012), TrackWise (since 2010), MES (since 2017) / digitalization, etc.