Dorina Moiceanu

Experience

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  Malva SRL / Verafarm SRL

  Dec 1989 - Jan 1991

  Pharmacist
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  University of Medicine and Pharmacy, Pharmaceutical Botanic Department

  Feb 1991 - Sept 1995

  University Tutor &Assistant
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  Europharm SA

  Sept 1995 - Jan 2012

  Member of the site leadership team, working actively on Strategy deployment to support GSK Objectives, taking a leading role in developing and implementing Quality and Compliance strategies and initiatives.Management of the Quality Department (Quality Assurance, Laboratory, Regulatory) counting +60 employees.Ensuring full deployment of GSK’s Quality Management System (QMS), ensuring requirements are both in place and in use. Developing, monitoring and fostering stepwise continuous improvement of key quality metrics. Ensuring appropriate Quality metrics are deployed effectively throughout the site and using metrics to drive improvement.Leading site quality risk management process and ensuring good root cause and mitigation strategies are in place. Ensuring appropriate governance and escalation processes are in use. Identifying Key Quality strategic goals, translating them into tactical plans and aligning organization and processes to deliver the strategy.Hosting regulatory agency inspections and ensuring site inspection readiness. Ensuring effective regulatory conformance and compliance programs are established.Building a Quality culture and a mind-set of compliance, problem solving and continuous improvement across site.Maximizing the expertise of Quality management team to implement a culture of execution and delivery, incorporating visual metrics and tiered accountability.Facilitating knowledge management and sharing best practices between site and GSK network.Applying Lean Manufacturing and Six Sigma principles in order to drive efficiency, reduce variation and waste and increase performance of managed processes. Show less

  • Quality Manager

    Jan 1999 - Jan 2012

  • Head of Quality Control Laboratory

    Jan 1998 - Jan 1999

  • Quality Control Pharmacist

    Sept 1995 - Dec 1998
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  Europharm SA, part of GSK

  Jan 2012 - Apr 2016

  Production & Process Improvement Manager

  Department overview:Total Staff Supervised: Up to 120Operating budget: around 2m EuroSales Volume impacted: approx. 40-45 m packsNo. of markets: Up to 90Capex: around 1.5m EuroNo. of SKU’s: Up to 300Market areas: Global markets (excepts USA and Brazil)Part of Site Leadership Team (Board Management).Managing activities and employees in the Production department, controlling the production processes, focusing on achieving plant’s objectives, maximizing results and minimizing loss.Responsible for increasing productivity, quality performance and yield through the application of lean manufacturing processes and continuous improvement. Responsible for implementing Quality and safety requirements in production area.Management of “transfer in and transfer out” products.Management of departmental activities associated to site closure as per Functional exit Plan (decommissioning activities, archiving, staff restructuring process). Show less

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  ROPHARMA S.A. BRASOV

  Jun 2016 - now

  Technical Consultant

  Acting as technical advisory mainly for GMP/ GDP issues in manufacturing activities and distribution direct reporting to the company CEO.Supporting all GMP projects and activities in the two manufacturing facilities (one located in Romania one in Republic of Moldavia, Chisinau)Ongoing review the GMP status versus local and EU GMP requirements, risks identification and mitigation plan issue and monitoringConsulting activities based on identified needs, in time support for training activities, SOP development, validation activities, etc.Continual improvement of manufacturing activities, having in focus both pharmaceutical aspects as well as an increase in efficiencyReview activities for bringing lean in day by day work, continue to embed the quality culture of doing things RIGHT FIRST TIME. Show less