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Principal Investigator

2 weeks ago

Dublin, Dublin City, Ireland GlaxoSmithKline Full time

GlaxoSmithKline is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together.

Job Overview

In this role, you will be responsible for providing Qualified Person certification as defined in EU directive 2001/20/EC, regulation 536/2014, Article 51 of Directive 2001/83/EC and performing QP release of a range of Investigational medicinal products.

  • Ensure a compliant operation is in place to allow for EU certification of batches of Investigational Medicinal Products and assure products meet regulatory requirements and that they conform to regulatory submissions.
  • Maintain knowledge of legislation changes and proposals applicable to QP Certification, evaluate impact and propose mitigation for their compliant management and/or introduction.
  • Provide QP advice and consultancy working with GSK project teams, external collaboration partners and external sponsors to reduce regulatory risk to GSK and ensure information and other QP assurances are obtained (as required).
  • Build and maintain effective internal GSK and External business relationships. Working with the senior EUQP's, develop and incorporate effective processes and procedures in Product Quality Pharma R&D and may contribute to business processes and procedures outside Product Quality Pharma R&D including coaching, mentoring, or training.
  • Participate in routine or regulatory audits and investigations, such as Quality Investigations, customer complaints and vendor complaints and make recommendations for corrective and preventative actions, and to follow up on the implementation of those recommendations.

Responsibilities

The ideal candidate will have extensive experience in pharmaceutical manufacturing and quality operations, with a strong background in quality management.

  • Science degree and/or QP eligible equivalent degree.
  • Eligible to act as Qualified Person in the EU (Ireland).
  • Experience with the QP certification of major dose forms such as Tablets, aseptic sterile manufacture and biopharm products.
  • Broad knowledge of quality management.
  • Capable of leading, and working in multi-disciplinary teams based in different geographical locations to develop value added-solutions.