QA Specialist

  • Cork
  • Temporary 18 months
  • Job Number JO-1902_1551099486

Summary

Responsibilities

  • Supports GMP activities from operational through to Laboratory support programs.
  • Partners with other Departments to ensure that compliance programs are completed in an efficient manner and are effectively maintained.
  • Responsible for implementation of systems and procedures for the management of change control and deviation management, as it applies to plant installations, systems, and operations in accordance with GMP.
  • Quality oversight of project activities including but not limited to, C&Q activities and process validation through to commercial manufacture.
  • Participates as a key quality member in inspections and audits of by external parties/agencies.
  • Key participant within the QA team in the execution of their duties.
  • Executes the activities of the group within quality to create a synergistic approach to goals and tasks.
  • Domestic and international travel may be required.

Requirements

  • Bachelor's Degree in a scientific/technical discipline required
  • A minimum of 3 years' experience in a quality 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 including those of FDA, HPRA, EMEA and other authorities.
  • Focus on patients and customers at all times.

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