Senior Pharmaceutical Manufacturing Expert

2 days ago

Dublin, Dublin City, Ireland beBeeProfessional Full time €60,000 - €80,000

Pharmaceutical Manufacturing Professional

We are seeking a skilled and experienced Senior Lead Qualified Person to join our Quality Assurance team in Ireland.

The role is an exciting opportunity to make a meaningful impact by ensuring the highest standards of quality and compliance in pharmaceutical manufacturing operations.

Job Description:

The successful candidate will be responsible for ensuring a compliant operation is in place to allow QP certification of batches of pharmaceutical products.

Key responsibilities include:

  • Ensuring QP certification of all batches of pharmaceutical products imported into EU in accordance with EU Guidance on GMP Part1, Annex 16 and Annex 21.
  • Leading/hosting regulatory inspections of the QP certification process.
  • Oversight of supply site operations via formal quality meetings with the site.
  • Supporting regulatory inspections of supply sites as required.
  • Auditing the importation supply chain to ensure compliance with GMP, GDP and MIA authorisation as required.
  • Actively representing the Quality Assurance team on assigned projects as required.
  • Mentoring and coaching junior members of the team.

Requirements:

The ideal candidate will possess:

  • Scientific degree.
  • Significant experience in pharmaceutical manufacturing and quality operations.
  • Experience with the certification of major dose forms (tablets, cream/ointments), aseptic sterile manufacture and biopharm products.
  • Experience in management of Manufacturer Importation licences.
  • Knowledge of GDP regulations.

Benefits:

The successful candidate will have opportunities for professional growth and development within the company. We offer a dynamic and supportive work environment that fosters collaboration and innovation.

How to Apply:

Candidates interested in this opportunity should submit their application package, including a cover letter and resume, to us. Please note that we do not accept applications through email or other external channels.

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