Sr Quality Assurance and Validation Expert

4 days ago

Cork, Cork, Ireland beBeeValidation Full time €45,000 - €60,000

Job Summary:

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We are seeking a highly motivated and organized Sr QA Validation Associate to join our team. In this role, you will be responsible for ensuring the quality of our products by implementing, requalifying, and decommissioning manufacturing processes, equipment, computer systems, laboratory systems, and changes to existing equipment.

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Responsibilities:

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  • Quality oversight of validation activities in a GMP regulated environment.">
  • Implementation, requalification, and decommissioning of manufacturing processes, equipment, computer systems, laboratory systems, and changes to existing equipment.">
  • Providing quality oversight for FUE activities related to BioMarin’s products and facilities.">
  • Supporting the development of validation plans for specific system implementation projects.">
  • Reviewing and approving project lifecycle documentation (URS, RA, Commissioning, Qualification Protocols).">
  • Maintaining current knowledge of industry standards and regulatory requirements.">
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Requirements:

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To succeed in this role, you will need:

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  • A Bachelor of Sciences degree or higher in a technical discipline (physical, engineering, chemical or biological sciences).">
  • At least 3 years' experience in a cGMP regulated manufacturing environment.">
  • Knowledge of equipment and utility validation, and laboratory systems/validation.">
  • Excellent organizational and management skills to coordinate multi-discipline project groups.">
  • Ability to comprehend technical information related to equipment, processes, and regulatory expectations.">
  • Experience with participation in regulatory inspections.">
  • Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations.">
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What We Offer:

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This role offers:

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  • The opportunity to work in a dynamic and innovative environment.">
  • The chance to contribute to the development of life-changing medicines.">
  • A competitive salary and benefits package.">
  • Opportunities for professional growth and development.">
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About Us:

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We are a global biotechnology company that is committed to developing innovative treatments for rare and serious diseases.

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Contact Information:

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If you are a motivated and organized individual who is passionate about quality and innovation, please submit your application today.

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