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Head of Pharmaceutical Manufacturing

1 week ago

Dublin, Dublin City, Ireland Mason Alexander Full time
Company Overview

Mason Alexander is proud to be partnering with a leading global pharmaceutical company to support their search for a permanent Quality Manager & QP to join their Dublin team.

The company's commitment to delivering high-quality products and services is unwavering, and we are seeking a talented individual to join their team.

This role offers a unique opportunity to work in a dynamic and fast-paced environment, with a focus on delivering exceptional results.

We are committed to providing our employees with a positive and supportive work environment, with opportunities for growth and development.

Responsibilities

The successful candidate will be responsible for:

  • Managing the Quality Management System (QMS), ensuring it is fit for purpose, making changes as necessary.
  • Managing communications with and representing the company in front of HPRA.
  • Providing QA expertise and managing any quality issues that arise to closure.
  • Supporting HPRA inspections and preparing written responses to inspections.
  • Providing QA oversight and expertise for new product introductions.
  • Reviewing and approving non-conformances (NC), CAPA, change controls, and complaints.
  • Reviewing and where appropriate, preparing and regular updating of technical agreements with licensees and 3rd party contractors.
  • Implementing the Self Inspection/Internal Quality Audit program.
Requirements

To be successful in this role, the ideal candidate will have:

  • A BSc (Hons) in Science or equivalent.
  • A thorough working knowledge of GMDPs and regulatory expectations for medicinal products and medical devices.
  • Minimum of 5 years of experience working in Quality Assurance in the healthcare industry.
Benefits

This role offers a competitive salary and benefits package, including:

  • A hybrid work arrangement, with 3 days in the office and 2 days from home.
  • A comprehensive training program, with opportunities for growth and development.
  • A positive and supportive work environment, with a focus on employee well-being.