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Alan O'Riordan
Life Science

+353873657522
[email protected]
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Details

QA Specialist


Reference:AOORAWBN-277574 Location: Cork
Cork City
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: QA Specialist

QA Specialist

Description
My client manufactures and distributes X-ray and MRI Contrast Media for internal and external customers worldwide. As part of the Pharmaceutical Diagnostics (PDx) business of the company, we support the PDx vision of being the best-in-class supply chain delivering the right dose to the right patient at the right time. At their campus at Cork, they employ approximately 600 staff and are a 24/7 operation exporting to 93 markets worldwide.

This is an opportunity for a skilled QA Specialist to join a team that manufactures and distributes X-ray and MRI contrast media for customers worldwide. As part of our 2024 vision for our manufacturing campus in Cork – of becoming a 50m to 60m unit (vials) capacity parametric release site – we’re set to introduce a new filling line. Reporting to our Platform Quality Leader, you’ll manage the site’s QA systems alongside other specialists in the QA Product Quality team. In particular, your role will involve coordinating and executing all QA duties for the QP batch release. The work you do here won’t just support our growth, it will enable us to deliver our life-changing equipment to even more patients across the globe.

Responsibilities

  • Ensure compliance with GMP, Company Corporate Standards, Quality Management System (QMS), site policies/procedures, regulatory requirements and industry standards
  • Partner closely with customers and stakeholders to understand and deliver on all activities within timelines and escalate when necessary
  • Lead & support cross functional/continuous improvement teams as required to provide consultative and collaborative support on quality related issues
  • Lead & support investigation root cause and resolution ensuring appropriate CAPA actions implemented to prevent recurrence where relevant
  • Author, track, manage change, review/approve/authorise relevant documentation types to include, but not limited to; SOPs, investigations, commitments (Regulatory Agency, investigation, audit, etc.), change controls, forms, logbooks, QC stability program, validation and batch release documentation
  • Lead & support management of relevant metrics/forums to ensure ownership and delivery of, and compliance with, key site metrics

Qualifications and experience

  • A level 8 degree in Science / Engineering discipline or equivalent knowledge and experience
  • Previous relevant Quality experience within a QA/QC GMP environment in a Pharmaceutical industry
  • Excellent communication and interpersonal skills.
  • An ability to work independently, as well as collaboratively within a team in a dynamic, fast-paced environment.
  • 2+ years in the pharmaceutical industry in a QA position

Desired Skills

  • Ability to create and maintain effective interpersonal relationships with all levels of personnel within all cross functional departments in the organization
  • Excellent communication, negotiation and risk based decision making skills, promoting openness, dialogue and collaboration
  • Results oriented with a strong ability to effectively troubleshoot and problem solve issues
  • Promote a continuous improvement culture.

Eligibility requirements
  • A good level of English and a valid work permit (Stamp 4/ EU Citizenship)
  • Must already be located in Ireland

For further information, contact Alan on [email protected] / 087 365 7522