Expert for the qualification & validation within the packaging process and for the relevant documentation and requirements
Experience within the pharmaceutical and medical industry, therefore well aware of GMP/GDP standards and the MDR norm
Has been placed by K-Recruiting multiple times and has always received excellent feedback
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Overview
- Availability
- Asap, 5 days/week, on-site & remote
- Qualification
- Engineering/Packaging, Diploma
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Qualification Engineer for Packaging Lines, Process Engineer, Packaging Qualification/Validation , validation of packaging process, Packaging specifications, FMEA, Risk Analysis, Feasibility, primary, secondary and tertiary packaging, GMP, Pharma & MedTech
Key-Facts
Extract from previous activities
Pharmaceutical Company, Germany (via K-Recruiting)
Packaging Validation Engineer
Documentation and release for packaging production lines
Qualification of packaging line
Conducting of documentation, URS, FMEA, FAT, DQ, IQ, OQ, PQ, SOPs
Validation of packaging processes
Qualification of inspection lines for pharmaceutical products
MedTech Company, Switzerland (via K-Recruiting)
Packaging Consultant
QA Compliance Engineering for medical devices industry
Qualification of packaging lines
Conducting of documentation for packaging line (e.g. SOPs, WI, URS, QNA, FMEA, SAT, FAT, DQ, IQ, OQ, PQ)
Validation processes (FMEA, Risk analysis for feasibility, transport validation)
Auditing of suppliers for packaging lines and production materials
Biotechnological Company, Germany (via K-Recruiting)
Packaging Consultant
Validation of packaging lines / processes for primary, secondary and tertiary packaging
Implementation /auditing of suppliers for packaging lines and production materials
Leading of development projects (syringes, foils, blisters, boxes)
Pharmaceutical Company, Germany
Packaging Validation Manager
Specification for production packaging, sterilization and cleaning processes
Support and review of documentation
Conducting of transport validation tests, statistics, documentation
MedTech Company, Germany
Packaging Validation Consultant
Track and Trace Process, Auditing, Self inspection internal standards
Validation of production processes (packaging process / GDP transport validation)
Pharmaceutical Company, Germany
QA Compliance Engineer
Conducting of documentation, CAPA, URS, QNA, FMEA, SAT, FAT, DQ, IQ, OQ, PQ
Validation of pharmaceutical processes (Risk analysis for feasibility, Qualification of Packaging lines, HAVC, AP, Pharma packaging process / GDP Transport validation)