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← Simtra BioPharma Solutions

Head of Q Compliance Releasemanagement / Qualified Person (Sachkundige Person gemäß § 15 AMG)

Simtra BioPharma Solutions
Location
Halle, North Rhine-Westphalia, Germany
Posted
20 days ago
Department
Quality Assurance & Regulatory Affairs
What they actually want (must-haves)
  • Qualification as Qualified Person according to §15 AMG or Article 49 of Directive 2001/83/EC
  • At least 5 years of leadership experience
  • Minimum of 5 years of professional experience in the pharmaceutical industry
  • Experience in quality control
  • Knowledge of sterile or aseptic manufacturing
  • Solid understanding of EU GMP guidelines, especially Annex 1 and Annex 16
What the job really is

In this role as Head of Release Management and Qualified Person at Simtra, you will lead a team responsible for batch release in compliance with regulatory and GMP requirements. Your daily tasks will include managing team resources, evaluating product quality deviations, overseeing documentation, and supporting audits and inspections. You will also be involved in training pharmacy students and participating in quality improvement projects.

Benefits
  • Modern in-house canteen with attractive subsidies
  • 30 days of vacation plus special leave
  • Job bike leasing
  • Corporate benefits with exclusive discounts for employees at numerous well-known brands
  • Good transport connections and free employee parking
  • Financial support for job-related relocations as part of the relocation cost allowance
Things to weigh
  • No salary information provided
  • The role requires strong leadership and technical expertise in a highly regulated environment
  • The position involves significant responsibility for product quality and compliance
Job score3.4/5
Benefits4/5
Freshness4/5
Career value4/5
Role clarity5/5
Pay transparency0/5

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