Profile: IRCA PQMS GMP Associate Auditor, CQI Practitioner. Customer audit, Internal audit & Supplier Qualification. Batch release and issuing Conformity Certificate, handling QP daily tasks. Acquainted with GMP, GDP, and GCP /ICH guidelines .QP-release experience in LBP DS, Narcotic API, and finished product Solid Dosage Form .Productions as CMO/CDMO validation, QRM handling . Master files handling SMF, DMF, CTD, and Quality system, Adequate experience in CAPA Change Control and Deviation handling and PQRs approval. Medical insight and drug safety advisor, experienced in GVP, post Marketing; .Author of the books titled : Practical EU GMP Audit Check List & GAP Analysis ,Practical Troubleshooting Tablet Manufacturing ,Qualitography handbook ,Practical GAP Analysis & Audit Checklist -Manufacture of Sterile Medicinal Products (Annex 1) +Toolbox for CCS ,PRACTICAL GAP ANALYSIS & AUDIT CHECKLIST, EU Good Distribution Practice (GDP) API, Medicinal Product & WHO. Languages 1) Persian: Native 2) English: professional 3) Danish: professional C 4) Norwegian: limited. IT skills 1) Full proficiency in MS office 2) Experienced in Quality management systems. Based in Denmark.