Peter Ebben Email & Phone Number

Arnhem-Nijmegen Metropolitan Area, Ge, Nl

Goch

Veghel

Nijmegen Area, Netherlands

Tasks and responsibilities:• Line responsible for all staff within the department, either direct or in-direct e.g. planning, coaching, scientific quality/knowledge, training and personal/career development.• Responsible for incoming inspections of raw materials, packaging materials and artwork according to GMP and ISO.• Responsible for final inspection of pharmaceuticals and medical devices according to GMP, ISO and MDD.• Responsible for market release of medical devices• Approval of test methods and in process controls.• Responsible for preparation and evaluation of batch documentation.• Responsible for cleanroom monitoring system.• Management of product specifications.• Trending of data and report trend analysis.• Setting, reviewing and reporting Quality Performance Indicators.• Root cause investigation after out of specifications.• Execution of internal and external audits.• Verification and release of equipment qualification

Currently the section Metrology is delivering service in managing all analytical equipment (appr. 700 items) for 4 analytical departments.Tasks and responsability:• Management of the section Metrology• Project leader investment projects.• Responsible for resource planning• Responsible for the content and quality of all validation documentation.• Responsible for GMP implementation.• Initiating and implementation of improvement process.• Verification and authorisation of validation documentation.• Budget and manage maintenance contracts.

Responsible for the analytical release of tox and phase 1 and 2A medication.Tasks and responsibilities:• Process development for analytical release for early phase development• Planning of analytical analysis.• Perform process checks.• Verification of analytical files.• Transfer analytical file to QP.

Performing analysis on solid pharmaceuticals and verification tasks.Used techniques and analysis:HPLC, GC, NIR, TLC, CE, dissolution, disintegration, physical measurements, moisture determination using Karl Fisher, cleaning certification, spectroscopy, method development, method validation and method transfer