GMP and quality assurance
Theoretical knowledge and practical experience as well. I have a fine understanding of quality management and the importance of audit readiness including structuring of quality systems, change management and handling of corrective and preventive actions and deviations.

Commissioning/Qualification/Validation of equipment, process plants, utilities, and facilities. Generally, planning, execution and documentation of factory and site acceptance tests, design, installation, and operational qualification as well as process validation and thermal validation including documents such as validation master plans, requirement specifications, risk assessments, protocols and reports.

Calibration forms a significant part of my experience including ISO- accreditation and activities.

Project management in relation to management of technical projects covering the responsibility for quality, time, and costs related to rebuilding and purchase of new production equipment.

Structured, purposeful, and persistent with a high focus on bringing an idea to the practical level, getting things done and reach goals on time.

Pragmatic, solution-orientated and adapt the situation/opportunities.

Take care of the quality, pay attention to details, and go in depth when needed.

Good at balancing the efforts between actions “here and now” and initiatives with a more long-term perspective.

Positive, sympathetic, and thinks before acting.

Open minded and respectful concerning the knowledge of others and personal contributions.