Senior QA Specialist

3 weeks ago


Dublin, Dublin City, Ireland Stemrp Full time

STEM Recruitment Partners are working with a pharmaceutical company based in Dublin West, that is seeking a Senior QA Specialist to join their operations.

12 month contract initially, with strong likelihood of extension

Up to €35-40/hour DOE

Full time onsite.

Job Responsibilities


• Perform and evaluate trending of the Quality Management Systems to support management reviews, investigations, and continuous improvement initiatives (i.e. quality management reviews, annual product quality reviews, trend analysis for quality events, etc.)


• Interpret and properly apply all applicable regulatory requirements


• Lead and/or support investigations through cross functional team involvement (i.e. RCA, etc.)


• Present investigations and deliver disposition recommendations to site leadership and Qualified Persons.


• Improve existing procedures or create new procedures to align with cGMP and regulatory requirements


• Review and approve procedures, protocols, reports, etc., as required


• Lead and/or assist with continuous improvement, compliance-based, and site projects


• Support lean manufacturing initiatives both at the site level and within the greater Quality/Operations organization


• Participate in internal audits as an SME or member of the audit team


• Participate in External audits as a Lead Auditor of the audit team


• Perform additional duties as directed by management


• Support the day to day management for QA Team and associated workload.

Department specific/Non-essential responsibilities:


• Support other Quality functions at the site through cross-training opportunities


• Drive Continuous Improvement projects on site from a Quality Perspective


• Ensure Compliance with current regulatory requirements

Job Requirements


• Bachelor's degree or higher in a scientific discipline (biology, chemistry or engineering)


4+ years of experience in a cGMP environment (Quality Assurance preferred)


• Effective communication, coaching/mentoring, and presenting skills


• Ability to manage change


• Self-motivated


• Independent and sound decision-making capabilities


• Team-oriented


• Project Management skills


• Leadership and emotional intelligence


• Ability to utilize statistics at a moderate level for trending and interpretation of statistical data


• Deliver on-time results / Time Management

CVs to


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