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Fresenius Medical Care

Operates dialysis facilities and renal care

Hygienebeauftragter

Regulatory & Quality (Life Sciences)Posted on Nov 13
Full-timeSankt Wendel, GermanyNo salary listedHybrid

About the Job

Requirements

  • A completed degree in a scientific, pharmaceutical, biotechnology, microbiology, or comparable technical field, preferably specializing in microbiology, pharmacy, biotechnology, process engineering, or a related field; alternatively, a comparable qualification with several years of relevant experience in a GMP-regulated environment.
  • Several years of relevant professional experience in the pharmaceutical or GMP-regulated industry, ideally in hygiene, microbiology, cleanroom technology or qualification, contamination control, or quality assurance.
  • Substantial experience assessing and managing deviations, change controls, corrective and preventive actions, and risk-based measures.
  • Experience creating, assessing, and maintaining standard operating procedures, risk assessments, contamination control strategies, qualification documentation, and other GMP-related requirements.
  • Experience professionally directing or coordinating internal interfaces and external service providers.
  • Experience with audits and inspections, including preparing for and supporting related activities.
  • Very good written and spoken German.
  • Good to very good English.

Responsibilities

  • Professionally direct and develop hygiene management.
  • Take responsibility for cleanroom qualification.
  • Manage contamination and hygiene risks.
  • Define and professionally justify hygiene requirements.
  • Manage governance and documentation.
  • Manage standards and requirements.
  • Manage training and qualification.
  • Conduct professional on-site oversight.
  • Manage disinfectants.
  • Manage cleanroom clothing and laundry.
  • Direct external service providers.
  • Manage hygiene monitoring and the microbiological environment.
  • Drive continuous improvement and harmonization.

About the Company

Fresenius Medical Care

Operates dialysis facilities and renal care

Fresenius Medical Care North America provides renal care through a network of dialysis facilities and outpatient cardiac and vascular labs that deliver coordinated treatment for chronically ill patients. It also offers specialty pharmacy and laboratory services and manufactures and distributes dialysis equipment, disposables, and renal medicines. The company stands out by being the world’s largest fully integrated renal care provider with an extensive network that covers care delivery, drug and lab services, and product supply. Its goal is to ensure access to comprehensive, high-quality care for people with kidney and other chronic conditions across North America.

Company size
11-50
Company stage
Late Stage VC
Total funding
$40.2M
Headquarters
Waltham, MA
Founded
1996

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