Senior Quality Specialist

  • Cork
  • Permanent
  • JO-1711-62983_1511436370

Summary

Responsibilities:

  • Support start-up activities from a quality aspect to ensure compliance
  • Support all quality and compliance requirements for the Biologics Integrated Process Team (IPT) to enable batch disposition for each batch manufactured.
  • Uses knowledge to improve Quality Systems and/or Operational Quality; solve complex problems, provide continuous improvement and execute tasks.
  • Coordinates the work of others within the team
  • Acts as a resource to colleagues with less experience in Quality Systems and/or Operational Quality
  • Active member/Lead (as required) within the cross functional IPT team providing quality expertise, support and advice to the IPT team on Quality Assurance and GMP compliance aspects.
  • Works within IPT to ensure supply of high quality product through implementation and oversight of the Quality Management System.
  • Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes
  • Interprets customer needs, assesses requirements and identifies solutions to non-standard requests.
  • Liaises with Corporate Quality to ensure alignment on actions related to Quality Systems and/or Operational Quality at the site.
  • Works with other sites to aid them and ensure alignment and best practices adopted for Quality System related topics and/or Operational Quality.

Requirements

  • At least 5 years' experience in the Pharmaceutical, Biopharmaceuticals industry or a similar operating environment which includes a minimum of 2 years' experience in a Quality Assurance/Quality Operations function.
  • Degree in Science, Engineering or similar
  • Green belt or suitable alternative (desirable).
  • Good communication & interpersonal skills.

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