Quality and GMP requirements

What you will get…

> 20 years of experience in biopharmaceutical manufacturing, QC and QA
Knowledge of International guidelines and requirements (ICH, EU, FDA, USP, Ph.Eur., Others)
Comprehensive experience with various QA topics:

Deviations, CAPAs, Change Control,

Manufacturer's release, Batch record review,

Product Specification files and regulatory compliance checks,

APR/PQR, Trending/Monitoring of Product Quality Data, Control Strategy, QbD elements,

Training, SOPs for Q-Processes

Support of Audits by various authorities and clients, Co-Auditor