A highly motivated, adaptable and forward-thinking quality assurance specialist with more than 4.5 years of pharmaceutical industrial experience in a fast paced and regulatory GMP environment. I have an excellent experience on reviewing and approving SOPs and other manufacturing documents, Quality Management System (such as market complaint, quality risk assessment, CAPA management, Change control management, Incident and Investigation), Internal Quality Audit, and Regulatory Inspection. I was actively involved in various regulatory inspections i.e. USFDA, MHRA, TGA, ANVISA, WHO, EMA during my professional journey in industry. I have an expertise as a quality operational technical representative in the preparation of and review of batch records, standard operating procedure and investigation report. Sound knowledge on 21 CFR Part 11, 21 CFR 210, 21 CFR 211, ICH Q7, Q9, Q10 and ALCOA guideline. Hands on experience for various GMP software-Trackwise (QMS Software), LMS- Learning Management System, FMS - Form Management System, Metis-ERP (Transaction Software) and MS Office.

Highlights:

Companies I like:

sun pharma, pfizer, novartis

• Manufacturing
• Pharmaceutical
• Quality
• Audit
• Complaints
• LMS
• Management
• Quality Assurance
• Test
• Video