GMP Expert

+10 years of experience as a freelance consultant for engineering projects in the pharmaceutical & biotechnology environment, including Single-Use lines and Upstream / Downstream

Strong interface between production and quality

Expertise includes the coordination of qualification, validations and maintenance activites as well as quality-related tasks such as changes, deviations and CAPAs

Has been placed twice by K-Recruiting and received excellent client feedback both times

Determination of the required documents for the new production area & gap analysis

Preparation and execution of PQs (in particular vial cleaning systems, depyrogenation tunnel, filling system, loading and unloading system freeze dryer, flanging machine, external cleaning machine, stopper treatment system, automatic cleaning machine, autoclave, inspection machines, utilities)

Preparation of risk analyses

Preparation of validation documents (including cleaning validation, sterilization of equipment, semi-automatic inspection)

Project management for the start-up phase (incl. creation of GMP-relevant documents)

Creation of processes and illustrations in SOPs

Execution of trainings of the SOPs

Verification of FAT/SAT and documentation

Perform risk analysis, qualification plans, IQ/OQ/PQ test plans, protocols and reports incl. CSV & automation for:

• Cell cultivation and bioreactors

• Ultra- and depth filtration

• Tangential flow filtration

• Multiple chromatography systems

• Filter integrity testers

• Small and laboratory equipment

• cleanrooms, airlocks with control and ventilation systems

• Cleanroom monitoring (temperature, humidity, MiBi, particles)

• WFI generation, storage and distribution, monitoring of WFI systems (MiBi, trending, process capability, etc.)

• Utilities

• Single-Use

Preparation of process validation plans & reports for solid forms and non-sterile liquids

Preparation and performace of qualification plans and reports for: Glove Integrity Test System (software, database and equipment), Glove Life Cycle System Software, IPC Equipment, LAF Units, Small devices, Single-Use

Conduct/lead a structured root cause analysis on observed analytical out of trend results in the context of tech transfer of a complex biotech product

In-depth analysis of available data, definition of a problem statement, formulation of hypotheses, proposal of experiments to confirm or falsify the hypotheses and finally to define the root cause and corresponding corrective actions and preventive actions

Assessment of the deviation from the point of view of risk management and submission to authorities

Preparation of a report on the Root Cause Analysis

Review and preparation of automation planning documents

Project management for the new installation of a CIP system

Review of CSV/IT maintenance plans/reports, migration documentation and data archiving

Creation of topology and EMSR plans for automation

Creation, review and commenting of CSV and DI SOPs, P&IDs and design docs

Spare part management of automation hardware and components

Technical support & document management

Preparation of commissioning, IQ and OQ test plans for:

• Vial washing machine

• Sterile isolators and LF units o Particle measurement equipment

• Depyrogenation tunnels

• Filling lines

• Capper

• Lyophilizers with backpusher

• Loading/unloading system

• Capping machines

• Tray loader

• Scada system