Shabbir Ahmed Robin Email & Phone Number

A QA professional with 6 years of experience in the solid and sterile manufacturing area at the dedicated Penicillin, Penem, and Oncology Unit. I have successfully participated in audits from regulatory bodies including EUGMP, UNICEF, Kenya, and Tanzania. I am proficient in Quality Management Systems, Batch Release, Risk Assessment, and Regulatory Compliance. Currently working in Eskayef Pharmaceuticals Limited as Assitant Manager- Quality Assurance. These facilities have been targeted to meet local as well as export markets such as the EU, UNICEF, Afghanistan, Kenya, Myanmar etc.Eskayef Pharmaceuticals Limited is a renowned medicine manufacturer in Bangladesh having FDA (Solid & Sterile), MHRA, ANVISA, and TGA certifications and finally achieved EU-GMP certificate for the Oncology unit in both Solid and Sterile facilities.My strengths as an Assitant Manager- Quality Assurance are,# Proficient in solid & sterile products (OSD, PFI, Lyophilized products) manufacturing at dedicated Penicillin, Penem and Oncology Unit. # Reviewing batch documents and planning & coordinating the release of finished products to the market. # Self-inspection programs & vendor audit. # Expertise in managing Quality Management Systems including handling Change Controls, Deviations, CAPA, Risk Assessment (utilizing FMEA Method), and Product Complaints.# Experienced in process simulation at sterile facilities, ensuring the integrity and sterility of products.# Document preparation, reviewing, and management (SOPs, Annual Product Quality Review, BMR, BPR, validation protocols, and reports).# Execution of Process Validation, Cleaning Validation, MACO Calculation, Hold Time Study, Campaign Length Study, and equipment qualification ensuring robustness of manufacturing processes.# Expert in the calibration of instruments including KF Titrimeter, Hardness Tester, Disintegration Tester, Friability Tester, Leak Tester, and Weighing Balance.# Proactively manage quality operators and follow up on routine in-process control works.I am also a social entrepreneur and an experienced member of the Board Committee with a demonstrated history of working in a non-profit organization named Aim Initiative Foundation.I am skilled in Management, Leadership, Quality Assurance, Risk Assessment, Audit, and Quality Management Systems. I am strongly positive-minded, keen to learning and networking, and also flexible in any situation.