POS 4993
Status 10

GMP-Quality/Manufacturing Consultant (M/W/D)

Beschreibung: For one of our Biotech clients in Germany we are seeking freelance support as: GMP-Quality/Manufacturing Consultant (M/W/D)
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  • Approval of production protocols according to §14 AMG (German Medicines Act)
  • Leads/coordinates complex deviations, identification of the right root cause (RC), identification of smart, effective CAPAs to avoid any re-occurrence of deviations. Compilation of deviation reports and risk assessments ready to be approved by QA.
  • Performance of data analysis and trending as a tool to foresee/tackle potential compliance/process issues (e.g. IPC warning limits excursions, drop in yields) in a proactive manner, as a tool to identify potential opportunities for process improvements and/or to understand root causes of more complex compliance/process issues right to intiate an appropiate remediation.
  • Supports preparation, successful conduct and follow-up of regulatory inspections, self inspections and customer audits as required and ensure optimal inspection readiness
  • Establishes GMP training, site quality policies, SOPs and practices to ensure a compliant production (cGMP, safety, environmental protection, health care, lean)
  • Initiate, coordinate and/or assessment of change controls. Ensure a compliant RTO (release to operation).
  • Ensure adequate training status across the respective Value Stream (cGMP compliance, safety and environmental protection)
  • Might act as compliance representative/SME on behalf of the Value Stream in projects or other initiatives
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  • Start: asap, latest October 2021 // Duaration: 4 months initially, end of year // Capacity: 5 days / week, minimum 4 days / week
  • 5+ years of professional experience in the pharmaceutical/biotech industry with specific knowledge in Quality and cGMP compliance including 3+ years’ leadership/team management experience.
  • Proofen experience in occupational safety and continuous impromenents methods
  • Experienced inspection situations with authorities (e.g. US FDA , Local German Health Authorities/Regierungspräsidium)
  • A Lean Six sigma Green Belt training is favorable
  • Must Have: Business fluency in English & German
Bemerkungen: WANTED: GMP-Quality/Manufacturing Consultant (M/W/D). Please contact +49 89 1890998 613 or Skills: English, GMP (Good Manufacturing Practice)
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Interesse geweckt?
Auf geht's!
Beginn: asap
Laufzeit: 4 months
Einsatzort: remote
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