mats P.

Founder @ INIONX | Senior CSV & Validation Lead | GMP Digitalization | C&Q | 21 CFR Part 11 | GAMP5

Greater Uppsala Metropolitan Area

About

Pharma Validation & Automation Consultant Most systems don’t fail validation — they fail in reality. I help pharma companies move from “compliant on paper” to fully operational, audit-ready systems. 40+ years in GMP environments: • CSV, GAMP5, 21 CFR Part 11 • SAT, IQ/OQ, commissioning • Deviations, CAPA & remediation • Automation & manufacturing systems 20+ years international experience. Focused on execution where it actually matters.

Experience

  • Senior konsult at Self-employed
    Jun 2024 - Present · 2 yrs 2 mos

  • Senior konsult at Self-employed
    Jun 2024 - Present · 2 yrs 2 mos

  • Section Manager at Novavax AB
    Oct 2021 - Jun 2024 · 2 yrs 9 mos

  • Design Manager at Pharmadule Morimatsu AB
    Aug 2018 - Jun 2024 · 5 yrs 11 mos

    Front end design and design management of modular facilites. Coordination of design disiplines and project management.

  • Section Manager. Processdesign. at ÅF
    Jan 2016 - Jun 2024 · 8 yrs 6 mos

    Directly responsible for allocation of resources and revenue generating activities within the modality and provides multi-functional leadership and strategic direction for customer projects and related products/services.This includes but not limited to: - Directly responsible for allocation of resources and revenue generating activities by coaching of direct reports and their Teams and help they achieve their true potential. - Provide Strategic multi-functional leadership and direction for related products/services/Pricing strategies - Customer meetings. - Leading and supporting product strategy projects focused on new business opportunities. - Working closely with all cross-functional groups in delivering effective execution plans and activities - Management of line activities for the section, including recruitment, training, development, motivation and leadership of staff in order to deliver agreed business objectives