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Quality Assurance Packaging Specialist

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BioMarin Pharmaceutical

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Location:
Ireland , Cork

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

This position within the QA department provides Quality oversight, support and knowledge to activities relating to Quality to meet BioMarin business priorities. The Quality Packaging Specialist will have proven capability in promoting Quality across cross-functional teams, to deliver high quality product, ensuring continuous process improvement. The Quality Packaging Specialist will model the BioMarin Leadership behaviors and understand the principles to drive a culture of continuous improvement building a High Performance Organisation.

Job Responsibility:

  • Provide Quality input and guidance to ensure packaging of high quality products in compliance with current Good Manufacturing Practices (GMPs)
  • Provide Quality direction and oversight of the development of new and existing processes in the packaging area to meet customer needs
  • Exercise judgment to determine appropriate action, ensuring proper escalation when non-conformances are identified as per applicable procedures for compliance, escalation and corrections within the packaging area of operations
  • Provide Quality input to Change Control/Deviations ensuring scope of record is clear and implementation activities are robust and timely
  • Review and approval of NCs and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable
  • Participates within inter-departmental and cross-functional teams, with direct interface with Manufacturing, Supply & Distribution, Maintenance, Metrology and Quality Control employees to immediately address issues and questions in real time to help ensure timeline are achieved to meet customer requirements
  • Minimising impact to packaging operations on site
  • Prioritizes tasks to ensure the critical tasks are completed on time and meet requirements
  • Review and release inputs for use in manufacturing as required
  • Write, review and approve Standard Operating Procedures in accordance with BioMarin Policies
  • Assignments may range from routine to more complex/non-routine projects/assignments, where analysis of situation or data requires a review of identifiable factors within the packaging operations area
  • Coordinates, plans, implements projects within specified objectives
  • Reviews executed packaging batch records and associated documentation
  • Participates in customer complaint investigations if required
  • Provides training and advice to staff in order for them to perform their desired functions
  • Participation in and leading internal inspections in the packaging area of operations
  • Prepare reports for Product Quality Reviews including batch listing and deviation trend reports to ensure that trends are acted upon and to demonstrate that products consistently meet desired critical quality attributes

Requirements:

  • Degree or 3rd level qualification (Science, Quality)
  • Demonstrated experience in packaging as the Quality contact for the area
  • Relevant experience (5yrs +) working in a Quality function in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the other requirements of the role
  • Demonstrates good knowledge of FDA / EMEA regulations/standards and quality systems
  • Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance
  • Demonstrated ability to work and succeed within teams as well as leading small project teams while maintaining and strengthening trust relationships with people on all levels
  • Strong organizational skills, including ability to follow assignments through to completion
  • Proficiency in PC skills such as Excel, Word, PowerPoint
  • Proven decision making capability with full accountability and responsibility
  • Demonstrated coaching skills
  • Excellent written and verbal communication skills
  • Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations

Nice to have:

  • Packaging QA function, with experience in blister seal operations
  • Evidence of Continuous Professional Development
  • Evidence of Validation knowledge/experience
  • MES experience
  • Good knowledge of Lean practices and root cause analysis

Additional Information:

Job Posted:
December 26, 2025

Employment Type:
Fulltime
Work Type:
On-site work
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