Qualified Person

Overview

We are seeking a Qualified Person (QP) for a 12-month contract role at a pharmaceutical company based in Waterford. The QP will play a crucial role ensuring licensed products are certified and released in compliance with EU regulations and Annex 16 requirements. Join a team operating in a cutting-edge sterile filling facility producing both commercial and clinical products, supporting a dynamic product pipeline.

Key Responsibilities

• Oversee the batch disposition process to guarantee prompt product release.
• Ensure compliance of batch disposition with site protocols and regulatory standards.
• Support major investigations, ensuring all deviations are resolved before batch release.
• Participate as Quality/Qualified Person representative in cross-functional teams.
• Provide additional QP support on quality-related issues when necessary.
• Engage in internal committees and teams as required.
• Offer guidance and advice to various departments on quality matters.
• Maintain independence in quality-related decision making as a QP.
• Foster partnerships across the organization to promote quality, compliance, and continuous improvement.
• Assist in internal auditing programs and supplier audits.
• Keep up to date with pharmaceutical legislation and industry best practices.

Requirements

• Advanced degree preferred; candidates should have eight or more years cGMP experience, especially acting as a QP named on the Manufacturer's/Importer's Authorisation (MIA), though relevant experience and education will also be considered.
• Proven leadership skills with at least two years in management roles.
• Postgraduate qualification (MSc or equivalent) mandatory.
• Experience in biologics manufacturing is highly valued.
• Familiarity with sterile manufacturing and clinical trials regulations is highly desirable.
• Strong training and mentoring capabilities.
• Excellent communication skills, both verbal and written.
• Competent in problem solving, risk assessment, and impact analysis.

Additional Information

This contract is based onsite in Waterford. The company values a culture of quality excellence and compliance. Candidates seeking further details may contact the recruitment representative directly via phone or email.

Company Background

CareerWise Recruitment, established in 1999, focuses on placing management and technical professionals in life sciences and related sectors across multiple locations in Ireland. They respect candidate privacy and operate with transparent data protection policies.