Quality Specialist

1 week ago

Dublin, Dublin City, Ireland Besins Healthcare Full time
Overview

Join to apply for the Quality Specialist role at Besins Healthcare.

About Us

Besins Healthcare is a global, family-owned pharmaceutical company specializing in the development and manufacturing of medical-grade hormones, with deep expertise in gynaecology, fertility, obstetrics, endocrinology, and hormone deficiency treatments.

We are dedicated to advancing reproductive hormone therapies that support the lifelong health and well-being of women and men. With a presence in over 90 countries, supported by 1,500 employees, 22 subsidiaries, and 5 production sites, our growth is driven by innovation and partnerships for distribution.

Job Purpose

Manage the Quality System functions, primarily focusing on Deviations and CAPAs, while supporting Documentation, Change Controls, Training, and overall risk management. The role involves working with both manual and electronic Quality Management Systems (eQMS) and is corporate and cross-functional, covering global products.

Key Responsibilities
  • Deviations & CAPA: Act as process owner; facilitate cross-functional meetings; guide investigations and root cause analysis; implement corrective/preventive actions; ensure effectiveness checks; harmonize and improve processes; maintain KPIs; support audits/inspections.
  • eQMS Administration: Manage deviations and CAPAs in eQMS; support IT with system validation and maintenance; act as SME; provide related training; support audits/inspections.
  • Audits & Inspection: Conduct internal audits; act as SME for audits/inspections; attend audits as required.
  • Other: Support additional QMS activities as needed; act as a quality ambassador.
Requirements
  • Pharmacist or Engineer with a Master's in quality, regulatory, or scientific field
  • 2+ years in pharmaceutical/biotech industry with experience in quality, regulatory, manufacturing, or development
  • Knowledge of GxPs, quality systems, EU/FDA/ICH regulations
  • Proficient in MS Office and SharePoint; experience with QMS preferred
  • Strong analytical, project management, and interpersonal skills
  • Ability to work independently and in a global matrix environment
  • Fluent in English; other languages a plus

Interested? Please apply and join us


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