2021-398 – Qualified Person – Waterford Full Time

Purpose:

This role reports directly to the QA Manager, you will be responsible for ensuring that practices at Company are in compliance with cGMP as stated in Directive 2003/94/EC and in the Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2002.

This critical role located onsite ensures that products are manufactured and released in accordance with cGMPs.

Responsibilities:

• Ensure practices and products released from the site are in compliance with cGMP as stated in Directive 2003/94/EC and in the Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2002.
• Provide oversight and support improvement of site quality systems and GMP practices.
• Review and approval of Quality documentation.
• Work with relevant departments to ensure timely closure of quality actions/ findings.
• Support investigation of deviations ensuring all product deviations are closed prior to product release.
• Complete all duties as per relevant local and global procedures.
• Conduct duties in a safe manner and report all safety issues or concerns.
• Maintain work area to good housekeeping standards.
• Lead quality improvement projects.
• Mentor QA Specialists.
• Actively contribute to continuous improvement initiatives.

Requirements:

• Third-level qualifications (degree in science or related discipline preferred) appropriate for eligibility for Qualified Person status.
• Minimum of 5 years experience in the pharmaceutical industry in a QA role.