Quality Systems Specialist

Quality Systems Specialist

Permanent - Hybrid

Dublin North

Your new company have a long and steady history here in Dublin. They have a very healthy pipeline in place and due to an internal promotion they are now seeking to hire a QA Analyst/QA System Specialist. Your primary focus is on maintaining Quality Systems and ensuring audit activities are scheduled and actioned.

Day to day

• Ensuring compliance with the site Change Controls and CAPA’s system and liaising with all Departments to ensure close out in a timely and compliant manner.
• Recording and investigating Customers Complaints as per company procedure, ensuring investigations are completed in a timely manner.
• Scheduling and executing Internal audits, assisting various Departments in identifying any gaps in quality systems and assisting in the closing of same. 
• Assisting in audits of onsite by both partners and regulatory agencies, providing support in document retrieval, review and preparation to present to auditors. 
• Reviewing site documents, ensuring compliance with site and corporate procedures and regulatory guidelines.
• Liaising with vendors in the case of non-conformance ensuring investigations are adequately completed to allow assessment of impact on product and processes.
• The Generation, Preparation and Submission of Product Quality Reviews to our Distribution Partners.
• Maintaining all log books and databases relating to QA quality systems.
• Ensuring that all Quality Assurance SOP’s pertaining to analysts functions are kept up to date and reflects current regulatory requirements.
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Is this for you; do you have the following;

• A minimum of third level Diploma in a life science discipline
• At least 2-3 years’ experience working within a pharmaceutical manufacturing solid dosage environment.
• Excellent attention to detail with the ability to critically review analytical data and to write professional technical reports
• Experience of Quality systems to include but not limited to deviation, out of specs, QA KPIs etc.

Skills in the following areas are needed for this role

Deviations, Investigations, Customer Complaints, CAPAS, Change Controls, QA Systems, PQRs.

This role offers flexitime as well as a full suite of benefits.

Reach out to [email protected]