35 years of experience in pharmaceutical and medical device environments, with extensive expertise in GMP Compliance, Quality Assurance, Quality Control and pharmaceutical manufacturing
More than 10 years of hands-on experience in Oral Solid Dosage (OSD) manufacturing including granulation, blending, tabletting, coating, process validation and technology transfer
Extensive expertise in Deviation, CAPA and Change Management, combined with Risk Assessments, Batch Record Review, qualification and validation activities in GMP regulated environments
Was placed as a Qualification Specialist with best references to AimQ via K-Recruiting
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Overview
- Availability
- Asap; full-time; remote & onsite
- Qualification
- Dipl.-Ing. Process Engineering
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- GMP, Solid Dosage Forms, Risk Assessment, CAPA & Complaint Management, Root Cause Analysis, GMP Compliance & Documentation, SOP Creation & Review, Batch Record Review, Process Optimization, Pharma
Key-Facts
Extract from Previous Activities
Pharmaceutical Company (via K-Recruiting)
Qualification Specialist / API Plant Commissioning
Independently overseeing a defined area of the plant during the commissioning phase
Conducting and coordinating functional and technical tests on the plant
Independently inspecting plant components, media systems and technical interfaces
Responsibility for technical documentation and document management
Pharmaceutical Company
Qualification & Commissioning Specialist
Qualification and Commissioning of Process Systems
Deviation and Change Management (preparation of GMP Documents and execution)
University Hospital
Senior GMP Compliance Specialist
Qualification of Clean media and Clean Room systems
Deviation and Change Management (preparation of GMP Documents and execution)
Pharmaceutical Company
Senior GMP Compliance Specialist
Qualification of clean Media (generation, storage, distribution)
Pharmaceutical Company
Senior GMP Documentation & Quality Systems Specialist
Review and preparation of GMP-Documents for Qualification of Clean media and clean room systems
CAPA & Complaint, Deviation and Change Management (preparation and processing)
Pharmaceutical Company
Project Manager GMP-Production
Technology Transfer and Implementation of a Coating process
Project Management
Preparation of GMP Documents for Qualification/ Validation
Report to Management
MedTech Company
Senior GMP Consultant
Commissioning and Qualification (C&Q, incl. URS, Risk Assessments) for pilot scale dispensing and a filtration system
Pharmaceutical Company
Senior GMP Consultant
For a Technology Transfer for a sterile biotech production blood fractionation system
Pharmaceutical Company
QA, Production Officer support
Compliance Officer as support for production officer
Qualification of systems
Manufacturing support, Fill - Finish of sterile liquids
Chemical Company
QC Head
Implementation of a new QC lab, authority audit to obtain the manufacturers license
lab systems qualification, method validation, cleaning validation, SOP-preparation