Qualified Person

Summary:

A Qualified Person is required for a biopharmaceutical company in Waterford. The incumbent will be responsible for ensuring that practices on site are following 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:

• Responsible to ensure that licensed product is certified and released to market by a Qualified Person named on the commercial manufacturing license in accordance with EU directive 2001/83/EC, 2004/94/EC and in accordance with the requirements of Annex 16.
• Manages the batch disposition process to ensure timely release of product.
• Ensures the batch disposition process maintains compliance with site practices & regulatory requirements.
• Support major investigations, ensuring all product deviations are closed prior to batch release.
• Participates in cross functional teams as Quality/Qualified Person representative.
• Provide additional QP support to quality related issues, as the need arises.
• Participates on internal committees/teams, as required.
• Provides advice and direction to other departments on quality issues.
• Ensure independence of the QP on decisions on quality related matters.
• Builds partnerships across the business to create a culture that demonstrates excellence in quality, compliance and continuous improvements.
• Provide audit support as required for internal auditing program and supplier audits.
• Maintain an up-to -date knowledge of pharmaceutical legislation and industry practice.

Qualifications & Experience:

• Preference given to candidates with advanced degrees, Post Graduate Qualification required (MSc or equivalent).
• 8 or more years of cGMP experience preferred with relevant work experience (2 years') acting as Qualified Person, named on the Manufacturer's/Importer's Authorisation (MIA); consideration will be given to other relevant experience and education.
• Proven leadership skills comparable to 2+ years of management responsibility.
• Biologics manufacturing experience highly desirable.
• Experience in Sterile Manufacturing and / or Clinical Trials Regulations highly desirable.
• Excellent training/mentoring experience.
• Excellent oral and written communication skills.
• Competent problem solving, risk assessment and impact analysis abilities.