Quality Specialist

  • Cork
  • Temporary 12 months
  • JO-1902-64217_1552054518

Summary

Responsibilities

  • Carries out tasks related to the administration of event management systems including Review & Approval of Event, Deviations, and Customer complaints.
  • Carries out tasks related to the management of batch records design and approval.
  • Carries out administration of the SAP Quality Management Module.
  • Carries out tasks relating to the management of site change control systems.
  • Compiles Annual Product Reviews.
  • Approves and compiles where appropriate validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.)
  • Reviews and approves SOPs/work instructions/forms from other departments on behalf of Quality Assurance
  • Co-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site.
  • Perform GMP audits on-site and vendor facilities as required.

Requirements

  • Bachelor's Degree in a scientific/technical discipline required
  • A minimum of 3 experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry.
  • Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
  • Demonstrated knowledge and application of industry regulations as they apply to quality, including those of FDA, IMB, EMEA and other authorities.
  • Ability to operate as part of a team is critical.
  • Customer focus
  • Innovative
  • Excellent communication skills both written and verbal
  • Attention to detail
  • Good problem-solving skills

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

Fastnet - The Talent Group
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The Life Science Specialists

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