Paun O.

Experience

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  Catena Management SRL

  Oct 2012 - Apr 2013

  Pharmacist
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  Catena Management SRL

  Jul 2013 - Apr 2014

  Chief Pharmacist
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  Help Net Farma

  May 2014 - Jan 2015

  Pharmacist
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  Sensiblu

  Feb 2015 - Apr 2016

  Pharmacist
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  Omega Pharma Romania

  May 2016 - Dec 2017

  Regulatory Affairs Specialist; Pharmacovigilance & Quality Assurance Responsible Person - Romania

  • Maintained compliance with the guide on the Good Distribution Practice for wholesale distribution for wide range of products: pharmaceutical, food supplements, medical devices, cosmetics, disinfectants and biocides• Established and preserved an effective pharmacovigilance system in compliance with national regulation and with company's pharmacovigilance procedures• Implemented, maintained and improved the quality system▪ Successfully managed the artwork process (active communication with internationallabelling teams, scientific support, preparation, checking, correction, revision, approval)▪ Hands-on experience working in a matrix-organization, both in-country and with above-countryteams▪ Preparation and/or evaluation of the documentation files for registration, renewal and variations formedicinal products, food supplements and medical devices Show less

• 

  Philips

  Dec 2017 - Jan 2022

  • Managing multiple projects for assuring compliance in different markets across CEE region with multiple deadlines • Monitoring local legislation in order to notify concerned internal stakeholders as applicable• Introduced and implemented NPI (New Product Introduction) tool to ensure product quality and compliant labelling across portfolio. Manage the review and approval of finished products manufactured in accordance with their approved specifications• Performing internal and external audits, including supplier performance management in due time. Co-leading negotiations with suppliers to ensure quality expectations are met. Co-driving quality and compliance development and/or improvement for the region, when needed• Acting as front office for all DEKRA (re)certification audits in the broad area of ISO 9001 and ISO 13485 including area of purchasing controls for Philips selected markets (Commercial Organization: North, SEE and Central)• Certified ISO 9001 and 13485 Lead Auditor and acted as SME in Audit preparation for local organisations (North, SEE and Central)• Coaching and training different company functions (procurement, Q&R, project managers, supply chain, consumer care, sales engineering) within selected Philips Markets on various regulatory standards• Developing quality transition plans to address the changes in the OneQMS Philips Quality Management System.• Performing VAS (value added services) implementation in Philips Market CEE • Prepare Management Review for each CO: North, SEE and Central• Support initiation and follow-up of CAPAs to address audit nonconformities and improvements • Periodically track QMS related KPIs and submit Customer feedback to ensure compliance for the Region (North, SEE and Central)• Represent Philips in country government and regulatory agencies (medical device, Consumer Protection Authorities• Continuous improvement of process effectiveness, by using Lean tools (Problem Solving, Kaizen, Daily Management) Show less • Manage Audit preparations and direct the Audit program with the involvement of the stakeholders• Support initiation and follow up of CAPAs• Ensure compliance with the applicable country regulations and Philips standards & policies• Review and approve product labeling and product related marketing communications• Create Q&R awareness level within the Organization by providing regular trainings for new employees during the Onboarding Induction program, for all PH employees during monthly Town Hall meetings or as part of the Audit preparations• Prepare local Management Review with the active involvement of the MT by providing their input to the content of the meeting• Monitor, track and define improvement strategies for QMS KPIs• Support Consumer Care Department in product quality & safety complaints activities and processes.• Implement together with the relevant stakeholders - VAS (Value Added Services) project to ensure product quality and customer satisfaction Show less

  • Quality & Regulatory Compliance Specialist PH - CEE; Quality Responsible S&RC - CEE

    Dec 2018 - Jan 2022

  • Quality & Regulatory Officer South East Europe

    Dec 2017 - Nov 2018
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  Synaptiq.io

  Feb 2022 - now

  Quality & Regulatory Project Manager
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  AARDEX Group - Medication Adherence Tools

  Jan 2023 - now

  Quality Assurance Manager