Beschreibung:For one of our Biotech clients in Germany we are seeking freelance support as:GMP-Quality/Manufacturing Consultant (M/W/D)
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
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)