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Quality Specialist - Quality Projects

Quality & Laboratory
Cork
Deirdre Duboy
Temporary
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Job Reference: JO-2208-66287_1667304251

Summary:

I am working with a pharmaceutical organisation based in Cork that has an excellent 12 MONTH contract opportunity for a Quality Specialist to join their busy site. If you have experience in quality validation and qualification within a GMP environment please reach out for a confidential conversation!

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.
  • 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

Requirements

  • Minimum qualification of a Bachelor's 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
  • Skilled in the execution of Risk Assessment and in the use of a variety of problem-solving techniques
  • Experience in projects, audits & inspections as QA SME
  • Experience in the current Quality and regulatory standards by FDA. EudraLex etc.
  • 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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