Sarfraz Ahmed – Quality Systems Manager/Trainee QP
A successful, motivated Quality System Manager with an excellent ability to take the initiative and make decisions to achieve product quality realisation in the fast pace, continuously evolving Pharmaceutical industry. Highly competent at implementing relevant solutions to problems or situational changes consistently ensuring compliance with good manufacturing practices and regulatory requirements. Excellent soft skills used for conflict and problem resolution through negotiations and persuasion. Completed QP modules (Technical) while working at Shire as Senior Quality Assurance Specialist. Have demonstrated experience and strong knowledge in solid oral dosage forms and Liquids orals. My skill sets include compliance in GMP/GDP regulations, Medical Devices, ISO Standards, Supplier and Third party auditing (Sterile and Non-Sterile CMO’s, API, Packaging Materials) and Business Process Improvement. Strong quality assurance professional with a B. Pharmacy -University of Karachi, MSc in Pharmaceutical sciences- University of Bradford and MBA-Coventry University.
Main Responsibilities
• Customer complaint and /or change control and / or quality event / CAPA
• Maintaining communications within and outside of the department
• Responsible for the development and management of the SVMP
• Hosting and managing MHRA, FDA and third party/customer audits
• Managing the site documentation control systems including maintaining the SMF
• Driving improvements across site including data integrity awareness
• Managing and leading product recalls and field safety corrective actions
• Representing Quality unit in Management Review Meetings and facilitating continuous improvement
• Development and maintenance of the Company’s Quality System
• Support technology transfer projects including process/analytical test method transfer
• Development of employees within the Quality function and delivering education and training
• Responsible for Quality documents review, auditing, documentation control and site wide training
• Act as RP onsite-Responsible for ensuring compliance of Good Distribution Practices.
• Action as SME for license issues related to batch specific variation or justification for quality related issues required notification to MHRA.
• Responsible for supplier qualification , evaluation and risk management
Sarfraz Ahmed-MRSC (494486)
Quality System Manager / RP/ Trainee-QP
B.Pharmacy / Msc Phm.Sciences / MBA-Innovative Management
Sarfraz.ahmed@aspar.co.uk