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 the following areas: gynaecology, fertility, obstetrics, endocrinology, and hormone deficiency treatments.
We are fully dedicated to advancing reproductive hormone therapies that support the lifelong health and well-being of women and men.
With a strong presence in over 90 countries, supported by 1,500 passionate employees, 22 subsidiaries, and 5 cutting-edge production sites, our continued growth is fueled by innovation, expanding current products into new territories, and partnering 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
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Key Responsibilitie**
* s:Deviations & CAPA
s: 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/inspection
* s.eQMS Administratio
n: Manage deviations and CAPAs in eQMS; support IT with system validation and maintenance; act as SME; provide related training; support audits/inspection
* s.Audits & Inspection
s: Conduct internal audits; act as SME for audits/inspections; attend audits as require
* d.Othe
r: Support additional QMS activities as needed; act as a quality ambassado
**r.
Requiremen**
* ts:Pharmacist or Engineer with a Master's in quality, regulatory, or scientific fie
* ld.2+ years in pharmaceutical/biotech industry with experience in quality, regulatory, manufacturing, or developme
* nt.Knowledge of GxPs, quality systems, EU/FDA/ICH regulatio
* ns.Proficient in MS Office and SharePoint; experience with QMS preferr
* ed.Strong analytical, project management, and interpersonal skil
* ls.Ability to work independently and in a global matrix environme
* nt.Fluent in English; other languages a pl
us.