Regulatory Affairs Specialist/Quality Assurance Supervisor
Alrazi Pharma Industries
Total years of experience :16 years, 7 Months
As a GMP Compliance Supervisor participate GMP inspection (Drug product) and lead TUV Rheinland inspection for ISO 9001, ISO 13485 and CE Certification (medical devices).
Accomplish Registration of 7 Human drug products and 2 Medicals Device with SFDA and more than 20 Products (Tablet and Capsule) with Drug Regulatory Authority Pakistan (DRAP) as a Registration and Regulatory Affairs Specialist.
Complete CTD file Preparation and Evaluation, Hand on eCTD manager software, Quality Assurance Auditing Skills and MS office.
GMP Certifications with Drug Regulatory Authority of Pakistan (DRAP).
Drug Product Registration with DRAP
Quality Assurance and Quality Control Department development and Operations
Prug Product Registration with DRAP
Quality Assurance and Quality Control Department development, management and Operations
Implementing calibration procedures, SOP’s, working instructions of all Operational machines as well as QA/QC Lab.
Manufacturing process monitoring and control
Consolidated course on pharmacology,clinical pharmacy,hospital pharmacy,Biopharmaceuticals
Pharmaceuticals Sciences