Qa Specialist

This role is for a QA Specialist on a 16-month contract, focused on quality system processes such as product reviews, managing regulatory requests, and supporting deviations and change controls. The position involves improving Quality Management Systems (QMS), supporting audits, and providing inspection support. Strong knowledge of QA systems, critical thinking, and excellent communication skills are essential to successfully navigate daily tasks and problem-solving.
Responsibilities: Collaborate across departments and teams to ensure regulatory compliance. Manage and process regulatory requests, including preparing site contributions for annual quality reviews. Support investigations, CAPA activities, and process improvements for Quality Management Systems (QMS). Conduct site compliance walkthroughs and provide training on QMS elements. Assist with inspections and audits by providing backroom support. Author, review, and approve controlled documents like SOPs, deviations, and change controls. Analyze metrics to identify trends and recommend improvements. Qualifications: 6+ years in a GMP environment with a BS, or 4+ years with an MS. Experience in the pharmaceutical industry, ideally in QA. Strong knowledge of cGMP, QA systems, and regulatory standards. Experience with Lean tools, root cause analysis, and problem-solving for deviations. Excellent auditing, investigative, and technical writing skills. Proficiency in Microsoft Office applications. Type: Permanent, Full time, Monday-Friday
Package: €Neg DOE
For a confidential discussion on this or any other current opportunity please contact Nicola Murphy IAC-Sep24

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