Your new company

Here, in Hays Recruitment, our Multinational client in Cork is hiring an QA Specialist II.

This role is a QA Specialist II, in the GSIUC QA Department, under the QA General Operations Support team.

This specific role is required to perform QA review of manufacturing and engineering records & associated documents and QA review & approval of procedures and GMP deviations. This position requires a sound knowledge of quality assurance systems, methods, and procedures.

The candidate will be required to exercise judgement, within well-defined and established procedures and practices, to identify problems and appropriate actions and to generate alternatives and recommendations within defined processes.

The candidate must be proactive in their daily activities and interactions.

Your new role

Essential Duties and Job Functions:

• Performs a variety of activities to ensure compliance with applicable cGxP regulatory requirements
• Reviews routine manufacturing and engineering documentation including batch manufacturing records
• Assists in the completion of manufacturing related customer complaint investigations
• Participates in authoring, reviewing and approving Standard Operating Procedures (SOPs)/other types of controlled documents
• Identifies deviations from accepted practices, exercises judgement to evaluate impact and determines appropriate actions

What you'll need to succeed

Knowledge, Experience and Skills:

• Prior experience in the pharmaceutical industry is preferred (ideally within a QA role).
• Working knowledge of current Good Manufacturing Practices (cGMPs) (FDA / EMEA standards and quality systems)
• Demonstrates working knowledge of quality assurance systems, methods and procedures.
• Basic knowledge of OPEX Lean tools, and root cause analysis tools are used for identifying and correcting deviations.

Typical Education & Experience:

• 4+ years of relevant experience in a GMP environment related field and a BS.
• 3 + years of relevant experience and an MS.

What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.

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