Qualified Person - Pharmaceutical Manufacturing

About the Role

A contract opportunity for a Qualified Person (QP) is open with a pharmaceutical client based in Waterford. This position spans 12 months, requiring three days per week onsite presence within a leading sterile filling facility producing both commercial and clinical pharmaceutical products. The QP will be instrumental in certifying batches and ensuring their compliance with EU pharmaceutical regulations and site standards, contributing to a dynamic organization with a strong product pipeline.

Key Responsibilities

• Oversee the batch disposition process to guarantee prompt and compliant release of licensed products.
• Ensure adherence of batch disposition to site’s operational practices and regulatory frameworks.
• Lead and support thorough investigations on product deviations, confirming all are resolved before batch release.
• Act as the Quality/Qualified Person representative within cross-functional team settings.
• Provide additional quality-related support and participate on internal committees or quality teams as necessary.
• Advise various departments on quality-related concerns, maintaining the independence required for QP decision-making.
• Foster partnerships across departments to uphold a culture dedicated to quality, compliance, and continuous improvement.
• Offer audit assistance during internal quality audits and supplier inspections.
• Stay informed on evolving pharmaceutical legislation and industry best practices.

Candidate Requirements

• Advanced degree strongly preferred; at least eight years of experience adhering to current Good Manufacturing Practices (cGMP). Relevant experience as a Qualified Person named on Manufacturer's/Importer's Authorization is highly valued.
• A postgraduate qualification such as MSc or equivalent is mandatory.
• Experience in biologics manufacturing is highly advantageous.
• Knowledge or experience with sterile manufacturing processes and clinical trial regulations is desirable.
• Proven leadership skills with a minimum of two years in a management role.
• Demonstrated excellence in training and mentoring team members.
• Strong oral and written communication skills.
• Ability to perform problem solving, risk assessment, and detailed impact analysis effectively.

Additional Information

This role reports to the manufacturing site in Waterford and requires physical attendance three days per week. The company values confidentiality and will handle applicants' data in accordance with stringent privacy policies. Interested candidates can inquire further by contacting the recruiting agency directly.

About the Recruiter

CareerWise Recruitment, established in 1999, specializes in sourcing management and technical professionals across life sciences and other sectors in Ireland. The agency operates multiple offices nationwide and prioritizes applicants' consent and data privacy throughout the recruitment process.