Responsible for execution of all internal verification and system/process audit activities, for alignment with relevant quality procedures, guidelines and directives to ensire permanent inspection readiness and to monitor status of GMP level and action steps.Execution with regards to preparations, execution and follow-up on inspections

Global QA-IT officer located and dedicated to the local Pharmaceutical Operations site for all the lifecycle related activities (validation/qualification, operational phase, retirement, changes, deviations) for Information Systems, Automation systems and Computerized Laboratory systems. Backup QA-IT Officer for Analytical and Microbiological laboratory systems.Subject matter expert within the Site Quality Group 'Computer and Automation Systems'.

QA officer dedicated to the local Pharmaceutical Operations site for the IT lifecycle activities (validation/qualification, operational phase, retirement, changes, deviations) of the local Information systems, Automation systems and Computerized Laboratory systems. Backup QAO for Analytical and Microbiological laboratory systems and activities.Qualified internal auditor for non-sterile manufacturing, API and automation systems.Subject matter expert within the Site Quality Group 'Computer and Automation Systems'.

QAO for all Analytical QC laboratory related activities, including Lab Equipment Qualification, Computerized Systems Validation, Method Validation and Transfers, Changes and Deviations.Subject Matter Expert for the 'Lab Equipment', 'Computer Systems Validation' and 'Maintenance and Calibration' Site Quality Management Groups. QAO for the local site validation for the preparation, migration and implementation of the global SAP, MES, LIMS systems.

Identification, planning and preparation of the required activities to facilitate and ensure an uninterrupted and compliant (in-progress) analysis transfer(s) from a German laboratory testing facility with specialized custom long-term automated analysis equipment, to the local site.This included the validation/qualification/commisioning of the equipment, facilities, utilities and the compliant transfer of analysis methods and in-progress samples.

Qualification, validation and implementation of laboratory equipment/systems including Computer System ValidationImplementation, setup and validation of a 21CFR 11 compliant departmental Lab Asset Management system.Setup and implementation of documentation and procedures to support the compliant operational use and maintenance for labsystems.Deputy section-leader for the departmental Equipment and Automation Management Group (6 FTE).

Lead for the definition and selection a new Incoming/Receiving Goods software application for the Incoming Material Handling Department.Interim section-leader for the departmental Equipment and Automation Management Group (6 FTE).

Ensuring and maintaining the setup, configuration, development, maintenance and validation of the application software (Documentum), the database (Oracle), operating system (Unix Sun Solaris) and the server hardware (Sun SPARC based) for the worldwide corporate Regulatory Document Management system.

Automation of the analytical laboratory processes by developing and interfacing software solutions for specific analytical applications (like several weighing, calculation and reporting applications).Development and support the full automation (robotization) of analytical test execution, using a Zymark Labrobot and single-purpose stations (dispensers, shakers, centrifuge, ultrasonic pulverisation).Operational maintenance and support of the departmental chromatographic data system (VAX/VMS & Multichrom), including the development of a fully automated interface with the LIMS system.

Testing of active ingredients and end products with a multitude of analytical techniques.Equipment maintenance and trouble-shooting engineer for the departmental HPLC systems.

Preparation and testing for diagnostic test-kist for hospitals (like Elisa)