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概要
I am a performance oriented and results focused Validation Manager who brings along over 15 years of experience in pharmaceuticals industries. I am well versed in analyzing validation test data, implementing operating procedures, identifying deviations from established process standards, studying product characteristics, and conducting qualifications tests of new or existing processes. Handled quality control and are in charge for validating various types of equipment and technologies. Directed compliance with quality processes to supervise and help verification and audit management in the relevant geography policies and procedures. I have completed MBA in Marketing from Karachi University and M.Sc. in Applied Chemistry from Karachi University.
My key skills include Product development, Equipment/AHU Qualification, Quality Assurance, Process/Area Validation, Cleaning Validation, Process improvements, Change Controls, Research and development, Audits Plans, Complaint Handling, Problem Solving and Communication Skills.
Currently I am engaged with Martin Dow Ltd, as an Asst. Manager Validation, where I am responsible for handling change controls and deviations and advice production related process improvements. Succeed subordinates and impart related training as required. Attached is my resume which showcases my progressive experience and successful track record for leading successful initiatives. My professional background and great industrial exposure coupled with an excellent track record makes me an ideal candidate for executive roles. As such, I would welcome a discussion regarding opportunities with your organization that fit my background.
工作经历
Assistant Manager Validation
• Execute Equipment Qualification, AHU Qualification, Process Validation, Area Validation, Water System Plant validation, Cleaning Validation and validation/qualification activities as per VMP schedule.
• Function in close coordination with Product development department.
• Expertly handle change controls and deviations and advice production related process improvements.
• Accomplish subordinates and impart related training as required.
Assistant Manager Validation
• Held accountable for the execution of Validation/Qualification activities as per VMP schedule.
• Successfully succeed subordinates and impart related training as required.
• Functioned in close collaboration with research and development department.
• Devised Cleaning Validation, Water System Plant validation, Media Fill Trial, Area Validation, Process Validation and Equipment Qualification.
Assistant Manager Quality Assurance
• Established internal training plan, internal audits plan and entire standard operating procedures (SOP’s).
• Applied quality assurance methodology to receive material, production, and finished goods while utilizing relevant schematics and established compliant processes.
• Handled complaints, deviations, change controls and suggests production related process improvements.
• Coordinated with managers to implement the company\'s policies and goals and ensuring that health and safety guidelines are followed by the employee.
Validation Officer
• Deployed Media Fill Trial, Bio-Tech Area validation, Water System Plant validation and Cleaning validation.
• Coordination with research and development department as well as execution of Validation activities as per VMP Schedule.
• Monitoring and implementation of air classification systems.
• Responsible for the Preparation of Validation Master Plan.
Quality Assurance Officer
• Implemented the QMS and EMS to monitor air classification systems and prepared annual products review reports.
• Attended classes on good manufacturing practices, housekeeping, first aid training &firefighting conducted by the company.
• Examined tablets, creams, capsules, syrups, injections etc.
• Formulated deviation reports when there is any discrepancy.
• Support in preparing SOP\'s, inspection of the documents and internal Audits.
• Familiar with the entire standard operating procedures (SOP’s).
QC Analyst
• Accomplished the analysis of finished products as well as involved in the water analysis and testing of finished products.
• Implemented the ISO 17025.
• Ensured proper data recording, reporting and documentation for all analytical testing.
• Monitored sterile as well as non-Sterile Areas.
• Preparation of chemical reagents.
• Responsible in the inspection of the documents.
