Qualified Person

A Qualified Person is required by CareerWise Recruitment for a 12 month contract position with our Waterford based pharmaceutical client. The Qualified Person is 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 Annex16. This role requires you to be 3 days on site. You will be part of a team that will allow you to work in a state of the art sterile filling facility. Our client produces both commercial and clinical products, with a very robust pipeline - why not be part of this excellent organisation?

Responsibilities

• Manages the batch disposition process to ensure timely release of product.
• Ensures the batch disposition process maintains compliance with site practices & regulatory requirements.
• Supports major investigations, ensuring all product deviations are closed prior to batch release.
• Participates in cross functional teams as Quality / Qualified Person representative.
• Provides 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.
• Ensures 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.
• Provides audit support as required for internal auditing program and supplier audits.
• Maintains an up to date knowledge of pharmaceutical legislation and industry practice.

Qualifications

• Preference given to candidates with advanced degrees; eight or more years of cGMP experience preferred with relevant work experience acting as Qualified Person, named on the Manufacturers/Importers Authorisation (MIA). Consideration will be given to other relevant experience and education.
• Proven leadership skills comparable to 2+ years of management responsibility.
• Post Graduate Qualification required (MSc or equivalent).
• 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.

Please call Louise Mulligan today for further information on or email: