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Please apply by sending your CV to Joanne Walsh at joanne@qsp.ie or call for more information.

QA Manager

06/04/20 Dublin Neg

Permanent full-time

My client, a rapidly expanding innovative pharmaceutical company, is seeking a QA Manager to join their team based just north of Dublin City Centre.

This is an excellent opportunity to join a company that are passionate about tackling complex pharmaceutical development projects and finding solutions for patients with unmet medical needs.

The successful candidate will report to the Technical Director and be responsible for managing the Quality Assurance function within their Dublin manufacturing facility.

Responsibilities:

  • Overall management of the Quality Assurance team including technical agreements, change control, deviations, complaints and annual product reviews
  • Manage the internal and external audit schedule
  • QA Review of batch manufacturing documentation and assisting in QP release
  • Maintain and co-ordinate the approved supplier qualification program
  • Oversee the SOP management system including update, logging and distribution
  • Contribute to the successful outcome of all regulatory inspections associated with company business, as required
  • Understand and keep up to date with new regulations and guidelines, and implement systems and procedures to incorporate these new regulations, if appropriate
  • Ensure that good GMP standards are maintained at all times
  • Work alongside the Technical Director and other Departments including QC, R&D and Production to ensure the company meets its strategic goals
  • Contribute to the design and implementation of best practice quality improvement programmes and company expansion programmes
  • Contribute, as required, to the development of a robust product pipeline without significant delays in the regulatory approval process
  • Be part of a positive employee environment and a work towards a culture of continuous improvement and teamwork through the use of training programs and development of people

Requirements:

  • BSc in a relevant scientific discipline
  • Minimum 5 years relevant experience in the Pharmaceutical industry within an EMA regulated environment
  • Thorough understanding of Quality Systems
  • Excellent report writing, organisation, communication, problem solving, decision making
  • Experience in people management
  • Proven presentation skills

Please apply by sending your CV to Joanne Walsh at joanne@qsp.ie or call for more information.

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