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QA Systems Specialist

Quality & Laboratory
Cork
Siobhán Lane
Temporary
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Job Reference: JO-2003-65069_1583854156

Summary:

Responsibilities:



  • Provides to the site knowledge and experience in Quality Systems especially related to Vendor Management.

  • Uses knowledge to improve Quality Systems, solve problems, provide continuous improvement and execute tasks.

  • Provides compliance contribution to project teams and leads small projects.

  • Coaches and guides colleagues within the site.

  • Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.

  • Responds to non-standard requests from customer needs.

  • Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.

  • Supports Corporate Quality to ensure actions at the site are executed.

  • Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable.

  • Participation in and leading internal inspections

  • Supplier management oversight

  • Ensures supply of high quality product through the implementation and oversight of the Quality System for the site.

  • Champion the highest Quality and Compliance standards for the site.

  • Ensure highest safety standards.

  • Additional activities as requested by QA Lead


Requirements:



  • Degree or 3rd level qualification (Science, Quality).

  • Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation

  • 3 - 5 years' experience in the Pharmaceutical industry or a similar operating environment which includes experience in a Quality function

  • Quality Assurance SME knowledge, from both operational and educational experience, is required

  • Knowledge and experience in interpreting current regulatory requirements and providing independent support to the site

  • 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.

  • Demonstrated ability to drive the completion of tasks.

  • Proven track record of providing independent Quality support to the site.

  • Advanced PC skills such as Excel, Word, PowerPoint.

  • Stakeholder management of multiple decision makers, auditors, cross functional teams by demonstrating the ability to maintain and strengthen trust relationships with people on all levels.

  • Proven decision-making capability with full accountability and responsibility.




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Siobhán Lane
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Quality & Laboratory
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