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Process Validator

3 weeks ago

Galway, Galway, Ireland beBeeQuality Full time €60,000 - €80,000

Compliance Improvement Specialist

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  • This role presents a fantastic opportunity to work directly onsite, collaborating closely with manufacturing and quality teams to drive improvements in compliance and process validation initiatives.
  • You will partner with manufacturing process owners to identify and remediate gaps in compliance.
  • Your responsibilities will include supporting manufacturing process validation activities (IQ/OQ/PQ), updating quality system documentation, and driving the closure of CAPAs and NCRs.
  • You will also provide clear and concise technical writing for quality and manufacturing procedures.
  • In this cross-functional role, you will collaborate with Quality, Manufacturing, and Regulatory teams to implement compliant solutions.

Qualifications:

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  • Bachelor's degree in Engineering or a Quality-related discipline is required.
  • A minimum of 2-5 years of experience in medical device manufacturing, quality, or remediation projects is essential.
  • Strong knowledge of process validation and CAPA/NCR management is necessary.
  • Proven technical writing and documentation skills are required.
  • Familiarity with quality standards such as 21 CFR Part 820 and ISO 13485 is highly valued.
  • Excellent problem-solving skills with the ability to take a problem statement through to a compliant solution are essential.
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Requirements:

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  • The ideal candidate must be available to work onsite in Galway.