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Quality Assurance Specialist

  • Location: County Westmeath
  • Job Type:Permanent
  • Sector: Science & Pharma
  • Contact Email: tina.cornally@collinsmcnicholas.ie
  • Job Ref: 19289

QA Specialist| Pharmaceutical| Hybrid working|Perm|Westmeath

Great opportunity for an experienced QA Specialist to join a dynamic and growing Pharma company based in Athlone, County Westmeath. The QA Specialist will take ownership of the company QMS and will report directly to the QA/QP Director onsite. The role will also offer a great opportunity for involvement in new projects and product launches into the European market. The role is hybrid working 3 days onsite and 2 days working from home.

Quality Assurance Specialist responsibilities;

  • Maintain Quality Management System processes in line with company procedures and cGMP for activities on-site (Batch Certification, Storage and Distribution)
  • Provide quality support and oversight for manufacturing activities conducted at third-party sites. 
  • Review and approval of Change Control requests, Deviations, Complaints and CAPA’s to ensure compliance with all applicable requirements
  • Lead and manage investigations and root cause identification for on-site deviations
  • Management of internal and external audits 
  • Lead and manage third party and vendor qualification activities 
  • Participate in interdepartmental initiatives for continuous improvement of procedures, processes and systems 
  • Provide quality support to product launches in new markets 

Quality Assurance Specialist Requirements

  • Relevant Bachelor’s degree (or equivalent) in a scientific discipline 
  • Minimum of 5 years’ experience within a pharmaceutical manufacturing environment, Quality Assurance role is essential
  • In-depth knowledge of EU/US quality-related pharmaceutical regulations 
  • Strong working knowledge of EU Regulations (USP, ICH, EU GMPs, FDA etc.)
  • Experience in conducting vendor audits
  • Working knowledge of EU/US validation requirements

**FULL SPEC ON APPLICATION**

For a confidential discussion and more information on the role, please contact Tina Cornally.

tina.cornally@collinsmcnicholas.ie