Contractors & Audits Specialist

IBSAGroup Ltd

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Planning and execution of audits
Quality system implementation and monitoring
Document management and revision
** IBSAGroup Ltd is seeking a Contractors & Audits Specialist to join their Quality Compliance team. The role involves auditing third parties, managing internal audits, and supporting quality system implementation in compliance with relevant regulations. **

Job Summary

  • The role involves collaborating with the Quality Compliance team to qualify third parties and manage internal and external audits.
  • The specialist supports the implementation and monitoring of quality systems aligned with cGMP/GDP, ISO standards, and regulatory requirements.
  • The position requires managing documentation, quality flows such as deviations and CAPAs, and supporting inspections and audits by authorities and clients.

Matching Summary

Match Score: 75

** IBSAGroup Ltd is seeking a Contractors & Audits Specialist to join their Quality Compliance team. The role involves auditing third parties, managing internal audits, and supporting quality system implementation in compliance with relevant regulations. **

Skills & Requirements

Must-have

  • planning and execution of audits
  • quality system implementation and monitoring
  • document management and revision
  • knowledge of cGMP/GDP and ISO standards
  • quality deviation and CAPA management
  • English written and spoken proficiency

Nice-to-have

  • problem solving orientation
  • proactivity and flexibility
  • ability to work autonomously
  • strong communication and relational skills
  • willingness to travel

Key Requirements

  • Degree in scientific disciplines
  • Minimum 5 years pharmaceutical experience
  • Knowledge of Eudralex Vol. 4 and CFR 21 Part 11, 210, 211
  • Experience with sterile production (plus)
  • Fluency in English
  • Familiarity with Medical Device guidelines ISO 13485

Work Rights

Not specified

Tailored Resume

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