Quality Operations Compliance Specialist

3 weeks ago

Sligo, Sligo, Ireland Quanta Consultancy Services Ltd Full time
Quality Operations Compliance Specialist - Ireland, Sligo - 12 Months Contract

Located on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for aQuality Operations Compliance Specialist to join their state-of-the-art pharmaceutical facility. They have invested $55 billion in research to discover and develop new medicines in the pursuit of scientific breakthroughs and changing people's lives. They have 50,000 employees around the world and are continuing to grow.

Essential duties and responsibilities for this role include, but are not limited to, the following:
  • Leading / Assisting in investigations arising out of product or manufacturing processes non-compliance.
  • Review/Audit of completed Batch Records.
  • Review of Manufacturing Logs as required.
  • Completion of quality review of operations documentation (SOPs, JSTMs, Risk Assessments)
  • Completion of Incoming Raw Material checks, including product status maintenance (as required).
  • Provide Stability Program Support, e.g. sample pulls, weekly checks, protocol generation (as required).
  • Administration of Quality Logs, e.g. QA Hold, Sample Request.
  • Lead operations floor daily walk around of manufacturing areas.
  • Drive continuous improvements and simplify site processes and procedure, specifically relating to the Operations function to ensure compliance is maintained at all times.
  • Other support as deemed necessary
Desirable Experience:
  • Third level degree in a science, quality or engineering discipline.
  • Ideally previous experience in a quality role
  • A minimum of three years' experience in a quality/operations role in a highly regulated GMP environment. Experience in biologics manufacturing is highly desirable.
  • Experience in aseptic processing gained within either a quality or operations role is highly desirable.
  • A strong knowledge of regulatory requirements is required.
If this role is of interest, please apply now
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