Qualified Person – QP

On behalf of my client, a consultancy company for the Life Sciences industry we have a new role for a Qualified Person to join the team.

We are seeking a highly experienced and driven Qualified Person to join the team. This is a permanent full-time opportunity

My client strongly believes that a supportive and healthy work life balance is critical for their team to be happy and successful, and so they offer truly flexible working hours as standard. This applies to both when and where you work, with autonomy and trust given to everyone in their team from day 1.

Purpose of Job

· To fulfil the Company’s requirements with respect to Qualified Person services, in accordance with Annex 16.

· To provide input for development and implementation of the Quality Management System

· To ensure compliance in terms of GMP

· To host regulatory agency inspections and customer audits

· To support internal and external quality audits as required

· To provide training in GMP as required

· Some IMP experience in terms of bringing IMPS into Europe and dealing with different scenarios would be hugely beneficial. Some sterile or biologics experience would also be a big advantage.

Main Duties and Responsibilities

To perform the Qualified Person duties in accordance with Article 51 of Directive 2001/83/EC as amended and Clinical Regulation 536/2014 These duties shall include:
Ensuring all activities associated with manufacture and testing of the medicinal product have been conducted in accordance with the principles of GMP
Ensuring the starting materials used comply with the requirements, the supply chain is known, and audits have been carried out.
Ensuring that the manufacturing processes and testing methods are validated and in accordance with the marketing authorisation.
Ensuring changes have been assessed and completed accordingly
Ensuring that the requirements of the product registration and of the manufacturer’s licence have been met
Ensuring that the legal requirements for nationally manufactured and imported products have been met.
For products imported from outside the European Union (EU) or European Economic Area (EEA) the QP should ensure testing within the EU/EEA to requirements of the product registration and any other tests to assure quality of the products, unless a Mutual Recognition Agreement exists between the EU and the third country concerned

Qualifications and Role Requirements

Degree in a scientific discipline: Chemistry, Pharmacy, Pharmaceutical Chemistry or biology.
A minimum of 5 years pharmaceutical industry experience
Attainment of the status of Qualified Person in accordance with the HPRA’s educational requirements, experience, training, and licensing (compliance with the requirements of Directive 2003/94/EC)
The QP shall reside and operate in the EEA
The QP should have a complete programme of Continuous Professional Development (CPD)
The QP should have skills for the management of the quality functions of the Company
Ability to work cross functionally within the Company and apply GMP and associated legislation

For full details & Job Spec email your CV to [email protected] or call Tina at +353 1 2784701

Thornshaw Scientific is a division of the CPL Group www.thornshaw.com

#LI-TD1