QA Specialist

  • Cork
  • Temporary 12 months
  • JO-1905-64482_1557999407

Summary

Responsibilities:

  • Batch Record Review & material release to ensure compliance with GMP requirements.
  • 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.
  • Supports all validation activities on site as described in the Site Validation Master Plan.
  • Approves and compiles where appropriate validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.).
  • Supports system qualification and process validation activities.
  • 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.
  • Participates in the introduction of new process or modified process steps, as part of a New Product Introduction Team (NPI)
  • Perform GMP audits on-site and vendor facilities as required.
  • Carries out tasks related to the administration of site supplier approval process.

Required:

  • 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.

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