More than 20 years of experience in the pharmaceutical industry
Versatile validation expert with experience in the laboratory as well as manufacturing
Select your region & language
Our content and services may vary by location.
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Overview
- Availability
- Asap, 5 days/week, on-site & remote
- Qualification
- Diploma Analytical Chemistry, BSc. Mechanical Engineering
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Method Validation, Process Validation, Clean Rooms, Qualification, FAT, SAT, Validation Master Plan, Root-Cause Analysis, FMEA, URS, Pharma, BioTech
Key-Facts
Extract from previous activities
Pharmaceutical Company, Germany
Validation Coordinator
Consulting for submission to PEI
Set-up and strategic consulting in validation activities
Preparation of risk analyses
GAP analysis for analytical validation
Preparation of MACO reports for cleaning validation
Preparation of process and cleaning validation plans and reports
Coordination of validation activities
Preparation of quality management manual ISO 17025 / 15189 (QMH) for the laboratory
Evaluation and assessment of analytical results
Medical Device Company, Germany
Interim Consultant Quality Management ISO13485
Assumption of the QMB area of responsibility
Maintaining and updating the quality management manual (QMH)
Consulting and support of the CAPA system
Planning and execution of process validation
Carrying out management reviews
Carrying out internal audits
Supervision of external audits
Biologics company, Germany
Senior Analytical Scientist
Implementation of a new analyzer for deterministic integrity testing (CCIT) of containers for liquid injectable sterile products (prefilled syringes)
Device qualification of new devices
Performance of device specific FAT and SAT
Planning and execution of method development experiments
Preparation of SOP's for instrumentation & analytical methods
Documentation and interpretation of results
Presentation of the results
Compilation of the test procedure
Validation of the analysis method (planning, execution of validation runs, reporting)
Biotech Company, Germany
Consultant Method Validation
Revision of the existing concept for purification validation for biotech products
Creation of SOP for SWAB Recovery and VRL (Visible Residue Limit)
Creation of SOP for Seed Management
Create SOP for process development with focus on Quality by Design (QbD) according to ICH Q8 and Q11
Establish a concept for the evaluation of leachables and extractables (L+E) for disposables accord to guidelines
Pharmaceutical Company, Germany
Consultant Qualification & Validation
Planning / supervision of qualification & validation activities quality control for WEK, IPC & release analytics
Prepare qualification / validation plans and reports
Coordinate and evaluate laboratory qualification activities URS/DQ, IQ, OQ, PQ: NIR, IR, Centrifugation, Particle measurement
Creation and evaluation of change control
(Bio-)Pharmaceutical Company, Ireland
Consultant Project Management Validation
Plan and supervise validation activities in virology, serology, microbiology, and physical chemistry
Evaluation of analytical methods for revalidation
Update and adapt SOPs for analytical methods
Plan, evaluate, and supervise the establishment of reference materials and SST samples
Plan & supervise validation activities for in-process controls
Prepare validation plans and reports
Act as SPOC during FDA inspection for Ebola vaccine validations and qualifications in QC
Create and evaluate Change Controls
Prepare and evaluate CAPAs
Execute Root Cause Investigations & Cause Analyses
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