Senior QA Associate

  • Dublin
  • Temporary 12 months
  • JO-1905-64479_1557931573

Summary

Responsibilities:

· Perform all activities in compliance with safety standards and SOPs

· Write, review and approve Standard Operating Procedures in accordance with Policies.

· Provide Quality support for triage and investigation of all classes of non-conformance (NC) events

· Review and approval of NCs and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable

· Participates in customer complaint investigations.

· Provides training and advice to staff in order for them to perform their desired functions.

· Perform Visual Inspection AQL inspections and provide quality oversight for the inspection program

· Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.

· Review and approve cGMP records (e.g., NC, CAPA, protocols, reports, SOP, etc.) ensuring compliance with appropriate documentation

· Support continuous improvement and Operational Excellence initiatives

· Any other tasks/projects assigned as per manager's request.

Requirements:

· University degree. Engineering or Science related discipline preferred.

· Relevant experience (4 yrs) working in the pharmaceutical or biotechnology industry

· Excellent written and verbal communication skills

· Experience working with dynamic cross-functional teams and proven abilities in decision making

· Strong organizational skills, including ability to follow assignments through to completion

· Experience working in aseptic operations, protein formulation, vial and syringe filling.

· Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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The Life Science Specialists

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