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QA Specialist

  1. Dublin
Dublin
  1. Contract
Competitive
  1. CAPEX Projects
01-05-2024
32468
QA Specialist - Life Science - Dublin 

Would you like to grow your career, whilst contributing to scientific innovations that are transforming patients’ lives? Our client, a globally renowned biotechnology organisation, and voted one of the top 10 best companies to work for in Ireland, is looking to recruit a QA Specialist to join their team.


Key Responsibilities: 
  • QA review and approval activities for:
  • Laboratory investigations and deviations and associated corrective actions.
  • Contract testing laboratories investigations and associated documentation
  • Operational SOPs, test methods, forms and directives
  • Annual product reviews
  • Trending reports
  • Laboratory equipment/instrument qualification protocols and reports
  • Protocols and reports for method validations and technical transfers
  • Change controls
  • Establishing best practices and continuous improvement initiatives, in collaboration with Quality Systems and Compliance, to ensure compliance of all QC activities to all applicable policies, directives, guidance documents and regulatory requirements.
  • Supporting the QC laboratory through global regulatory agency inspections and achievement of market approvals.
  • Supporting the execution of the internal audit program.
  • Supporting QC and QA Network Harmonisation initiatives.

Qualifications and Experience:
  • Minimum of a BSc in Science or related discipline
  • Minimum of 3 years Quality experience in the biopharmaceutical industry
  • A thorough understanding of cGMP requirements for laboratory compliance including equipment and instrumentation qualification requirements is essential.
  • Excellent written and verbal communication skills
  • Ability to work on his/her own initiative in addition to working as part of a team
  • Ability to work across a team matrix in order to meet accelerated timelines
  • Excellent time management & organisational skills along with a proven ability to multi-task  

If this role is of interest to you, please apply now! 

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