Helen Malliaras

Experience

• 

  Ego Pharmaceuticals

  Apr 1986 - Apr 1999

  This role reported to the Scientific Director, extended scope in developing and implementing quality systems across the company and suppliers in addition to quality control supervisory responsibilities. This role reported to the Scientific Director and involved managing the QC laboratory (raw materials, packaging and products) troubleshooting for production, resolving manufacturing issues and building relationships with suppliers to ensure supply and delivery of compliant quality materials. Extended scope in later years involved developing and implementing quality systems across the company and suppliers. This role reported to the Scientific Director and involved developing and implementing pharmacopoeia assay methods for raw materials and products.

  • Quality Systems Manager

    May 1996 - Apr 1999

  • Quality Control Supervisor

    Apr 1987 - Apr 1996

  • Analytical Development Chemist

    Apr 1986 - Mar 1987
• 

  GlaxoSmithKline

  Mar 1999 - Apr 2008

  This role reported to the Quality Systems and Auditing Manager within the Quality department and involved auditing, preparing and reporting monthly KPIs and metrics, monitoring quality performance, running continuous improvement projects and implementing CAPAs, innovative ideas and solutions for QMS issues. This role reported to the Head of Quality within the Quality department and responsible for the staff within the Operational Quality Site Services Department. This role reported to the Quality Systems and Auditing Manager and responsible for internal auditing, preparing and reporting monthly KPIs and metrics, monitoring quality performance, running continuous improvement projects and implementing CAPAs, innovative ideas and solutions for QMS issues. This role reported to the Computer Validation & Compliance Stream Lead and was responsible for the document control of all project documentation and deliverables against iQMS standards and controls. This role reported to the Operational Quality Site Services Manager and involved auditing, monitoring quality performance, running continuous improvement and OE projects and implementing CAPAs, innovative ideas and solutions for QMS issues. This role reported to the Operational Quality Manager and responsible for the quality aspect of operations of non-sterile products and batch release. Additionally, quality management for the introduction of new products into production and all associated approvals and documentation.

  • Senior Documentation & Projects Specialist

    Apr 2006 - Apr 2008

  • Acting Operational Quality Site Services Manager

    Oct 2005 - Mar 2006

  • Senior Documentations & Projects Specialist

    Apr 2003 - Sept 2005

  • SAP Project Compliance Officer

    Apr 2002 - Mar 2003

  • Compliance Specialist

    Apr 2000 - Mar 2002

  • Operational Quality Officer

    Mar 1999 - Mar 2000
• 

  Lazar Anode Technologies LLC

  Apr 2008 - Apr 2009

  VP Administration

  Lazar Anode Technologies LLC is a joint venture company involved in the commercialization of proven novel technology for a continuous carbon baking furnace which bakes green carbon anodes for use in aluminum smelting. Location: Owensboro, Kentucky US.Role: Responsible for the set up and subsequent efficient and effective running of all administrative activities associated with operations. Areas covered included financial, HR, taxation, payroll, procurement, OH&S and IT.

• 

  SeerPharma Pty Ltd

  Oct 2009 - Oct 2012

  Senior Consultant

  SeerPharma is an independent, international consulting group providing technical and consulting advice to the pharmaceutical, biotech and medical device industries. Principle areas of expertise include:• Training and Development• Quality Systems and Quality Improvement Strategies• Gap Analysis and Audits• Validation Planning• Process Validation• Cleaning Validation• Equipment Validation• Validation Protocols and Reports

• 

  CSL Seqirus

  Jan 2012 - now

  • Senior Project Manager, Project Management Office

    Aug 2020 - now

  • Senior Process Manager, Supply Chain

    Sept 2017 - Aug 2020

  • Process Control Manager - Influenza Manufacture / ASU Lead

    Sept 2016 - Aug 2017

  • Process Control Manager - Influenza Manufacture

    Sept 2012 - Sept 2016

  • Consultant - Compliance Quality Advisor, Education and Coaching

    Jan 2012 - Oct 2012