概要

• Ensure, Prepare, and submit registration dossiers for medical product registration in the required format.
• Follow-up input request from Drug Regulatory Authority of Pakistan to ensure successful product registration.
• Ensure local regulations are observed and implemented within the company.
• Coordinate with global regulatory and DRAP for all regulatory related issues.
• Dealing with certain issues pertaining to QC/Regulatory.
• Maintain the registration status in SAP

工作经历

公司标识
Manager Regulatory Affairs
Dr.Salim Ahmed & Co.
Jul 2017 - 代表 | Karachi, Pakistan

• Ensure, Prepare, and submit registration dossiers for medical product registration in the required format.
• Follow-up input request from Drug Regulatory Authority of Pakistan to ensure successful product registration.
• Ensure local regulations are observed and implemented within the company.
• Coordinate with global regulatory and DRAP for all regulatory related issues.
• Dealing with certain issues pertaining to QC/Regulatory.
• Maintain the registration status in SAP

公司标识
Senior Executive Officer
SGS Pakistan (Pvt.) Ltd
Jan 2013 - Mar 2017 | Karachi, Pakistan

• Working experience in Gas chromatography mass spectrometry (GC-MS) and Gas chromatography electron capture detector (GC-ECD), Spectrophotometer, pH meter, HPLC.
• Identify and clarify job requirements before starting any test procedure.
• Ensure the equipment calibrated, Standard Operating Procedure (SOPs), Standard, Work instructions and Test Environment appropriate.
• Ensure the Quality Control data, documentation and also preparation for the audit.
• To assist the senior in the Method development, Method Validation and Research and Development work.
• Working in organic analysis Azo Dyes, Pentachloro phenols, ortho phenyl phenols, Dimethyl fumarate, Organtin, Pthalates Tests.
• Working in inorganic analysis pH,Formaldehyde,Chrome,Nickle,Heavy metals in spectrophotometer, AAS, ICP-OES and ICP-MS.
• Expertise in ISO, DIN, EN, LFGB, BS EN ISO and In House Method of Analysis.
• Responsibilities in Lab Testing, Inspection, Verification and Results Reporting.
• Comply with the relevant safety requirements and instruction. Ensure the proper housekeeping in their respected area.

学历

University of Karachi
硕士, 科学硕士学位, MSc Chemistry‎
Chemistry
2012

技能

熟练 Time Managment , Task Oriented

语言

熟练 英语