Quality Assurance Administrator 302 views1 application

Job Description

MAIN PURPOSE:

 

To provide administrative support to the Distribution Quality Organisation ensuring compliance with Good Distribution and Manufacturing Practice across all distribution activity, including transportation from manufacturing entities through distribution across the network and activity in affiliate companies.

 

KEY RESPONSIBILITIES & ACCOUNTABILITIES:

 

Support for Distribution Quality team in developing and maintaining the Distribution route compliance data. Define and maintain updated supply maps for all products.

Support routine management and maintenance of Distribution master data/information, including temperature data, route profiles, product profiles.

Support in maintenance of serialised data; support in activities required to maintain compliance within Tracelink / EMVO portal.

 

Support in ensuring timely release of products as required, within the remit of Norgine BV MIA.

Maintain temperature data as received from monitoring routes into software database; generate route profiles; analise data and escalate issues or out of trends to Distribution Quality Manager.

Maintenance and full administration of Distribution Quality SharePoint site:

  • Maintain license library and ensure information is up to date; ensure access is granted to all entitled personnel;
  • Monitoring and collation of Distribution metrics;
  • Monitor and maintain oversight on damages tracker;

Provide administrative support for Associate Director, Distribution Quality and the team, as required.

  • Development of presentation slides
  • Support in RP Forum and Global Distribution Quality Council meetings; agreeing agenda, managing presenters and taking and distribution of minutes, as required
  • Follow up on assigned actions from meetings

 

RELATIONSHIPS:

 

  • Reports to the Distribution Quality Manager
  • Senior management and technical / operational teams to organise and support meetings
  • Distribution Quality Manager and team for day to day support and assistance
  • Norgine administrators to ensure smooth operation of own activity and
  • External organisations to support Distribution Quality activity
  • IT functions for the maintenance of the functionality of the SharePoint and other systems

 

SKILLS & KNOWLEDGE:

 

  • A scientific / technical degree is desirable, with 0-1 year experience in a medium to large sized organisation and knowledge of EU/FDA guidelines for the manufacture and distribution of pharmaceutical products. Previous vacation/placement work experience if newly graduated.
  • A working knowledge of Quality Management Systems is desirable.
  • The ability to be creative and flexible while maintaining compliance will be critical to the
  • success of this position.
  • Analytically strong with highly developed knowledge and ability to use IT systems, particularly MS Word, Excel and Powerpoint to enable process improvements and the conversion of data into meaningful business information.
  • An eye for detail.
  • Project management experience desirable but not essential, well developed planning skills with ability to meet deadlines required.
  • Excellent verbal and written communication skills.
  • A team player.
  • Excellent networker with the ability to collaborate and agree outcomes.
  • Ability to communicate effectively with Norgine business partners.

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Norgine is a leading European specialist pharmaceutical company with a direct commercial presence in all major European markets. In 2017, Norgine’s total net sales were EUR 345 million, up 17 per cent.

Norgine employs over 1,000 people across its commercial, development and manufacturing operations and manages all aspects of product development, production, marketing, sale and supply.

Norgine specialises in gastroenterology, hepatology, cancer and supportive care.

 

Norgine is headquartered in the Netherlands. Norgine owns a R&D site in Hengoed, Wales and two manufacturing sites in Hengoed, Wales and Dreux, France.

 

For more information, please visit www.norgine.com

In 2012, Norgine established a complementary business Norgine Ventures, supporting innovative healthcare companies through the provision of debt-like financing in Europe and the US. For more information, please visit www.norgineventures.com.

NORGINE and the sail logo are trademarks of the Norgine group of companies.

Please note that we do try to provide specific feedback to all applications, however sometimes due to the volume of applications received we can respond only to those candidates who best match the position requirements.

 

 

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  • Address Amsterdam, Netherlands
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