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View Cache (Job ID 13826118)
Employer Morgan Mckinley
Job Title Quality Specialist
Description

Quality Assurance Specialist - Pharmaceuticals- Tipperary

Job purpose:

The ideal candidate will have strong Quality and Technical understanding of Operations and Compliance requirements in the Pharmaceutical Industry.

Key Responsibilities:

  • Complete review and approval of site documentation
  • Supports the site compliance plan and quality metrics generation
  • Leads walk down and scheduled audits
  • Participate in the preparation for and hosting of regulatory and customer audits
  • GMP training delivery to site personnel
  • Investigation of Supplier Complaints / Raw Material Deviations / Customer Complaints
  • Provide Quality support to Deviation and Laboratory OOS investigation.
  • Provide Quality guidance to Operating procedure review and approval
  • Provides support to Process and Validation review
  • Generation of Technical & Quality agreements
  • Generation of Annual Reviews and Product Quality Reviews
  • Participate in Quality and site projects that may arise.
  • Production batch record review pre and post production
  • Clinical and development support Deviation and OOS investigation support
Experience and Education:

  • Minimum of Degree in Science, Pharmacy or Engineering.
  • Qualifications as Qualified Person in accordance with Article 49 of Directive 2001/83/EC is an advantage but not required.
  • Relevant GMP standards
  • The Quality System
  • Site procedures and policies
  • Site equipment, layout, documentation
  • Laboratory testing and documentation
  • Validation
  • Understands key business drivers and uses this knowledge to make decisions and prioritise

Morgan McKinley is acting as an Employment Agency in relation to this vacancy.

Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.

This job originally appeared on RecruitIreland.com
Location Tipperary
Date Added 17 days ago
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