Quality Assurance

Veronika has spent over 10 years in the Pharmaceutical QA arena including process and cleaning validation , equipment qualification (IQ/OQ/PQ) & software validation, change control including regulatory submission support, compliance, annual product reviews, statistical analysis, complaint management, compliance review and inspection readiness, internal auditing, third party management, deviations, investigations, CAPA, stability program, batch review and batch release.

She worked with MCA/MHRA GMP regulations, ICH requirements, FDA expectations and industry best practice.

She then spent 10 years in the medical device diagnostics industry in the QA arena as senior Quality manager of a manufacturing site; later of a global Supply Chain QA organisation owning the Purchasing Control system End 2 End from product development/ supplier selection to supplier management to distribution warehousing.

She worked with ISO 9001, 13485 and CFR 820, 210/211 regulations as well as ISO 14971 Risk Management standards and was involved with all of the above including Field actions/ recalls, Risk Management files, managed annual Notified Body audits and several FDA inspections as the Quality Management System Representative of the site.

She has experience in two large multinational companies with Quality System consolidation and redesign and can assist your organisation with quality management system development and continuous improvement including integration of quality risk management into the quality system, at the same time reducing the opportunity for human error and non value added deviations.

She can also assist you with getting ready for ISO or regulatory inspections or targeted Quality System improvements.