25+ years of experience as project manager
20+ years of performing QA processes, validation, audits
Familiar with all current GMP, GDP, MDR standards
Strong production and packaging background
Select your region & language
Our content and services may vary by location.
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Overview
- Availability
- Asap, full-time, onsite & remote
- Qualification
- Diploma Engineering / Packaging
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Quality, Project Management, Production, GMP, GLP, MDR, Packaging, Validation, Risk Management, Auditing, QA, Medical Devices, Life Sciences, Pharma
Key-Facts
Extract from previous activities
Pharmaceutical Company, Germany
Project Manager
Project realization in the form of planning, implementation and control of the construction of a packaging plant at the new location and the dismantling of the plant at the old location
Main focus: Planning the relocation procedure, developing and monitoring the overall schedule, overall coordination of all relocation activities and service providers, monitoring adherence to deadlines, start-up management, cost control
Risk management: Identification and documentation of current risks in the project and their change during the course of the project as well as problem solving of operational disruptions during and after the merger
Communication/contact person for all project participants and interface for stakeholders and internal customers
Support with decisions regarding overarching resource and capacity planning
Pharmaceutical Company, Germany
Labelling and Packaging Process Management
Support of RA department and labelling management
Manager Packaging Processes, Remediation of workflows, SOPs, work instructions
Digitalization and Coordination of development processes with CMO
Pharmaceutical Company, Germany
Interim Head of Production
Leading of pharmaceutical production
Release of Batch Records
CAPA/ Root Cause Analyses / Risk Management / KPI / FMEA / SOP / OOS
Pharmaceutical Company, Germany
Supply Chain Consultant
Support of Supply Chain Work Flows
Conducting and review of technical agreements
Implementation of workstream for CMO production
KPI / FMEA / SOP / QTA / Risk Management
Pharmaceutical Company, Germany
RA/QA Engineering
Support Licensing Business
Conducting of QA documentation, URS, FMEA, GDP
Validation of production processes of pharma and packaging production