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Quality Systems Associate

  • Salary: Negotiable
  • Job type: Contract
  • Location: Dublin
  • Sector: Science
  • Date posted: 30/11/2017
  • Job reference: J378226A

Quality Systems Associate

My client is seeking to recruit a Quality Systems Specialist for a period of 12 months, based in Dublin, responsible for supporting the implementation of quality systems within the Global External Manufacturing organisation.

Responsibilities will include (but not limited to):

  • Maintain the document management system as required including management of templates, allocation of document numbers and review of draft documents.
  • Authoring, review and approval of Quality Systems related procedures
  • Supports the ExM team for preparing for area and regional Quality Council meetings in addition to provision of relevant information/metrics for presentation
  • Supports the Deviation Management process as per the ExM procedures, facilitating the Investigation Review Board
  • Support Quality Systems Specialists in management of the quality systems as required.
  • Act as the primary point of contact for the storage of Quality Documents within the ExM Document Archive
  • Compiling and performing GMP training to all ExM personnel, when appropriate.
  • Support the management of quality documents (SOPs, Quality agreements, templates, forms) and records and maintain associated trackers as required.
  • Support the on boarding of new personnel.
  • Quality systems Framework Champion, facilitate the timely review of Corporate Quality System Framework directives/SOPs and policies and co-ordinate responses back to HQ.
  • Author, track and make obsolete QSF document exception requests as required
  • Facilitate the timely ExM review of regulatory inspection observations from other sites for site compliance.
  • Collate metrics on a monthly basis.
  • Prepare trend and status reports as required.
  • Prepare and update training documents, courses and assessments. Deliver training to all relevant site personnel.

Qualifications and Experience required:

  • Preferably a degree in Chemistry or Engineering or Science related Degree.
  • A working knowledge of Quality Systems, preferably FDA or EU GMP
  • A minimum of 2 years' experience in an API or Drug product environment, 1 of which must be in a quality systems or related role.

Essential

  • Good time management and organisational skills
  • Ability to multi-task numerous projects
  • Ability to work with initiative
  • Good interpersonal skills
  • Good communication and presentation skills

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