QA Operations Lead

3 weeks ago

Cork, Cork, Ireland Fastnet Full time

QA Operations Lead

Setting the Quality Standard for the site, providing site QA support and management of the Systems & Compliance group.

Responsibilities:

  • Ensure that the site quality standards are embedded, measured and sustained in line with Regulatory and Global requirements.
  • Preparation and management of the Annual Site Quality Management Plan.
  • Providing Overview to site leadership team on the status of the site's quality system through Site Quality Governance Board and Annual Quality Management Review.
  • Ensure Global and Local QA Projects and Initiatives are resourced as required.
  • Support Quality Culture and Data Integrity on site.

Requirements:

  • Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent.
  • At least 8 years' experience working on a manufacturing site (e.g. QA and/or Production) or equivalent experience from external company or other line function. 4 years' experience leading a team.
  • Good working knowledge GMP regulations required within the pharmaceutical industry.
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