Compliance Specialist

Start date: Immediately

Duration: 6 month from start date

Home Office: Yes, fully remote

Responsibilities:

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• Compliance with and assurance of the quality requirements for raw materials in the GMP environment
  
• Responsible QA representative for raw material-specific aspects during the entire manufacturing process of a pharmaceutical product as part of an interdisciplinary team
  
• Responsible for reviewing and approving raw material-specific documents (QC plans, sampling instructions, bills of materials, etc.)
  
• Processing and supporting OOS investigations, deviations, CAPAs and change control processes
  
• Support for supplier qualification activities
  
• Subject matter expert in regulatory inspections and audits
  

Requirements:

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• Bachelor of Science in the field of natural sciences (e.g. biology or chemistry)
  
• Professional experience in the GMP regulated environment of the pharmaceutical industry
  
• First professional experience in the field of quality (QA or QC) in the pharmaceutical industry
  
• Experience in dealing with stakeholders at various levels
  
• Initial experience with TrackWise, SAP, LIMS and DMS is desirable