Munich, Bavaria, Germany
In pharmaceutical and healthcare settings, my focus is on the Global QMS, GxP Quality/Regulatory Compliance and Computerised Systems Validation across multiple business areas. Regulatory fluency across GxP Guidelines, Pharmaceutical Quality System, 21 CFR Part 11, EU cGMP Annex 11 and 15, Data Integrity, ISPE Good Automated Manufacturing Practice (GAMP), main MHRA and FDA Guidance(s) for Industry. Pioneering AI/ML quality assurance and validation frameworks aligned with evolving legal requirements. The views expressed with this profile are my own and do not reflect the opinions of any employer or affiliated organisation.
Main Responsibilities: • GxP Computerised Systems Compliance, Quality & Validation Manager. • Managing the delivery of projects on budget and on time while maintaining the company's profit margins and quality standards, delivering P&L and the overall performance of the service delivery • Key Account Management, identifyng the needs of both new and current customers in order to aid them in their success using our services • Managing, hiring and training diverse staff in a cross-cultural international environment ensuring development in their roles • Supporting Corporate PMO organisation Broad experience in the pharmaceutical environment, visiting many firms and manufacturing plants across Europe, including Oral Solid Dose, Sterile Dose, API and Biotech facilities: • Validation of R&D and QC Laboratory Automated Systems, such as Water's Empower 3 Chromatography Data System, Spectrophotometers, TOC systems, client-server titration systems, etc. • Validation of Process Control Systems, such as HMI-PLC based Manufacturing Process Equipment, Automation Systems, SCADA, EMS / BMS, Sterilisers, Autoclaves, etc. and supporting implementation of Manufacturing Execution System (MES) PAS-X from Körber and relevant interfaces with SAP ERP, LIMS, and Automation Systems integrated through middleware platform (e.g. during an M&A program) • Validation of Enterprise IT Systems, such as SAP ERP, LIMS, ArisG LifeSphere Drug Safety, eCTD, Trackwise system, eQMS/eDMS, etc. • Validation of Software as a Service (SaaS) IT-Cloud solutions for implementations at Corporate level • Support to Pharmaceutical Quality System Compliance, Change Controls, Events, Internal Audits, Deviations and CAPA Management • CSV & Data Integrity Compliance Assessment at site and global campaign levels. Execution of field assessment activities as Lead Assessor, definition of strategies to outline remediation action plans, directing critical business relevant conversations with company leadership / stakeholders.
Technical Project Management & Support to the UK Branch Operations • Managing and definition of GxP systems validation strategies, including plant-wide validation and QA remediation programmes for our clients • Overseeing the writing and execution of systems validation planning, specifications and IQ, OQ and PQ activities, including deviations management, Gap Fixing and periodic reviews, as required • Ensuring that all GxP systems maintain their validated state in line with EU cGMP Annex 11 and 15, US FDA 21 CFR Part 11, ICH, MHRA, PIC/S and ISPE guidelines • Generating, amending and implementing Standard Operating Procedures (SOPs) conducting training thereafter to relevant staff as required • Managing a team of brilliant engineers, ensuring performance and development in their roles • Coordinating Operations in UK & Ireland, levereging of synergies with Corporate PMO, supporting the hiring and office management for the UK Branch
I worked for many Life Science companies to support validation and quality assurance projects and to enable clients to reach a higher level of compliance for GxP computerised systems. Main topics of expertise: • Validation of R&D and QC Laboratory Automated Systems • Validation of Manufacturing Process Control Systems • Support for Validation of Management Information Systems • EU GMP Eudralex Chapter 4 Annex 11 and US FDA 21 CFR Part 11 Compliance • ISPE Good Automated Manufacturing Practice (GAMP) guidelines
Extracellular vesicles sorting with microfluidic devices and interaction with superparamagnetic nanoparticles for biomedical applications.