Job Description

The Qualified Person is responsible to ensure that licensed Finished Product is certified and released to the 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.

 

To ensure that investigational medicinal product (IMP) is certified and released to sponsor by a Qualified Person named on the IMP Manufacturing License in accordance with EU directive 2001/20/EC and in accordance with the requirements of Annex 16 and Annex 13.

Principal Responsibilities

  • Principal certification of batches of products prior to use in clinical trials and prior to release for sale and placing on the market.
  • Provide quality and compliance guidance on all critical and major quality matters.
  • Provide support to Regulatory for Regulatory submissions (IMPD, MAA) / QP declarations and License updates.
  • Creates an environment for ‘right first time’ in focusing on principles of lean, visual management and building in efficiencies as necessary from a systematic and compliance perspective
  • Review and approving of APQRs as required
  • Provide audit support as required for internal auditing program and supplier audits.
  • Maintain up-to-date knowledge of pharmaceutical legislation and industry practice
  • Any other duties as required by management.

Will be required to work on-site 2 -3 days (on average) most weeks, and some weeks will be required for 5 days. 


Requirements

Qualifications

  • Minimum 5 years of GMP related experience in biopharmaceutical/pharmaceuticals.
  • Eligible and demonstrated ability to act as Qualified Person within EC/EEA.
  • Detailed experience of Quality Assurance of aseptic medicinal products and in particular biopharmaceuticals.
  • Must have excellent communication skills, including excellent written, interpersonal, collaboration, and negotiation skills, with a team-oriented approach.
  • Extensive demonstrated pharmaceutical quality experience.
  • Must have thorough knowledge of biopharmaceutical/pharmaceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP/GDP requirements.
  • Must have demonstrated understanding of the processes and interactions essential for ensuring and maintaining regulatory compliance.
  • Must have strong task management skills with the ability to prioritize, schedule, and control under tight deadlines.
  • Must have a minimum of 1 years’ experience acting as a Qualified Person

Education:

  • Bachelor’s degree required; Post-graduation would be an advantage.
  • pharmaceutical legislation

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