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Quality Assurance Manager

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Waterford
  • Sector: Other
  • Date posted: 07/06/2017
  • Job reference: J367162A

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Quality Assurance Manager

Our client is looking for an experienced QA Manager to lead their quality team. This will be a strategic role providing leadership for the quality team and providing the site with strong QA oversight, anticipating QA needs within the business. They are looking for someone with a strong QA background but a person who would have a broad exposure to multiple departments and ability to ensure that QA is integrated well within operations.

Key Responsibilities

  • Provide quality expertise and oversight of cGMP activities across the site.
  • Ensure operations are in compliance with cGMP.
  • Manage QA team to provide quality and compliance support for the site.
  • Ensure Qualified Person support for site and global batch release.
  • Manage preparation and support for regulatory and external inspections.
  • Ensure effective management and support for internal auditing, customer complaints and periodic product reviews.
  • Support departments on matters related to investigations and finished batch releases. In particular, close contact maintained with the QC, Manufacturing, Process Engineering and Supply Chain

Skills & Experience required

  • Degree in Science or related area (Chemistry, Microbiology or Pharmacy preferred)
  • Post-graduate studies as appropriate to augment primary degree
  • Qualified Person status
  • 5 - 7 years' experience working in the pharmaceutical sector including sterile manufacturing.
  • 5+ years' experience as a people leader (teams or projects)
  • Project Management Experience
  • Hosting of Regulatory and Corporate Inspections
  • Operational experience of quality systems in a dynamic manufacturing environment.
  • Technical knowledge of sterile manufacturing and pharmaceutical plants
  • Understanding of Quality Management Systems and cGMP for US and EU.
  • Effective facilitator with strong leadership skills.
  • Excellent communication skills (interpersonal, presentation & writing) and able to effectively communicate technical & non-technical information
  • Natural influencer and works well as part of a multi-functional team.
  • Highly motivated and self-resilient.
  • Adaptable and flexible as well as a pragmatically minded problem solver.
  • Energetic in the pursuit of improved processes and ultimately improved performance.
  • Focussed on development of direct reports.

There is an excellent package on offer for the right candidate

If you are interested in this role contact Aine Fanning on 01 6455250 or email for a confidential discussion

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