Quality Specialist

  • Cork
  • Temporary 24 months
  • JO-1901-64214_1551707285

Summary

Responsibilities

  • Ensure that quality standards are implemented on the project
  • Ensure compliance with quality and industry regulatory requirement
  • Provide professional and timely inputs/directions and ensure the right level of quality in projects.
  • Prepare data/reports to communicate outcomes of quality activities.
  • Attend meetings (e.g. board/project/portfolio/department meetings).
  • Identify training needs and organize training interventions to meet quality standards.
  • Ensure update of Quality documentation: write Procedures and directions for recording and reporting quality data in projects, for documentation owned by Quality departments.
  • Ensure the link between Project Manager and Regulatory Responsible on site.
  • Reviewer/Approver of Change Controls.
  • Reviewer/Approver of Qualification/Validation Documents (e.g. validations (master) plans/reports, (User) Requirement Specifications, DQ, IQ, OQ, PQ, PPQ/PV, RCL, RTM, risk assessments, SOPs).
  • QA oversight of qualification and validation activities on the project
  • Participating in continuing professional development in order to maintain awareness in current and new regulations and ensuring new regulations are implemented.
  • Execution of Risk Assessment and in the use of a variety of problem-solving techniques


Requirements

  • Minimum qualification of a Bachelor Degree in a scientific/technical discipline required
  • 5 years' experience working with quality and cGMP in the pharma industry.
  • Experience in C&Q and life cycle qualification/validation support.
  • Experience working across a Global business a distinct advantage, projects, audits & inspections as QA SME
  • Experience in the current Quality and regulatory standards by FDA. EudraLex etc.
  • LEAN and Six Sigma philosophy are embedded in your day to day working
  • A good communicator and when collaborating
  • Work independently with strong personal drive
  • Strong attention to detail and organisational skills
  • Have the ability to critically assess issues and devise and execute appropriate solutions using problem solving techniques in a decisive manner
  • Travel may be required as part of the role to represent Global Quality on elements of project implementation

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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The Life Science Specialists

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