Adam Karpinski

Bewertung von Temperaturabweichungen in Transport und Lagerung als Dienstleistung für QA-Teams in Pharma und Biotech: Logger-Export plus Stabilitätsdaten, MKT- und Arrhenius-Bewertung, Entscheidungspaket zur Unterschrift der Sachkundigen Person. Für Lebensmittel- und Kosmetikbetriebe (BRC, IFS, ISO 22716): Wasser- und Schädlingsmonitoring mit Laborbefund als Nachweis und Schulungsnachweise je Verfahrensversion. Jede Zahl im Bericht ist per Skript reproduzierbar. Hosting in der EU.

Major projects: - Global Interim Quality Control Director - Interim Quality Director - Quality Assurance Manager - Senior Quality Consultant - Global Batch Release Improvement Project As a Quality Leader, I played a key role in supporting Quality and process improvement in the Pharmaceutical business in EMEA and US. This included streamlining processes, increasing efficacy, supporting strategic planning, and conducting supplier audits to ensure compliance and quality standards were met. -- Streamlined p

- Developed and implemented the digital transformation strategy for ERP, LIMS, eQMS, and MES for biotechnological CDMO - Designed computer systems validation (CSV) procedures, ensuring seamless regulatory compliance. - Managed key contractors and validation projects, improving system efficiency and usability.

- Directed multi-site quality control operations, ensuring GMP/GCP compliance. - Managed a €5M+ CAPEX & OPEX budget, optimizing laboratory performance. - Responsible for area digitization and corroboration - Labware LIMS administrator and Project Manager

- Led post-acquisition QMS integration, merging two sites into a harmonized quality framework. - Developed stability programs, equipment qualification, laboratory CSV and Lean quality improvement initiatives - Led Change Management & Increase laboratory efficiency by ~60% in 3 year - Redesign Stability program and equipment qualification to meet GxP requirements