Highly motivated and detail-oriented Production Professional with over nine years of experience in the pharmaceutical industry. Proven track record of ensuring GMP compliance, Data Integrity, optimizing production processes, and delivering quality products. Strong problem-solving skills and a collaborative team player. I am seeking new challenges and opportunities to contribute to the success of a dynamic pharmaceutical organization. I hold a bachelor’s degree in pharmacy and completed a second degree in Project Management.I have a proven work history of successfully executing a high-speed automated facility project for small-volume parenteral ampoules. My Key Skills / SME area includes Sterile operation Project, SAT, FAT Equipment and Area Qualification, Capacity Utilization, Aseptic processing and Practices, Aseptic Process Simulation (Media Fill), Process Development and Optimization, Dry Heat and Moist Heat Sterilization, Sterile Operation, Sterility Assurance, Drug Manufacturing, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), Data Integrity (ALCOA), Quality Assurance, Qualification, Validation, Audit Observation and Compliance. As a subject matter expert, I have actively contributed to Quality Risk Management, Quality Management Systems, and Contamination Control Strategies. Involved and successfully qualified MHRA audit (Medicines and healthcare product regulatory agencies, UK), WHO-Geneva audit, Mexico audit, Turkish medicines and medical device agency, Russian Federation and various regular customer audits.I acquire Strong understanding and knowledge of Quality risk management (ICH Q9 guidelines), Aseptic processing (PDA guideline), Sterilizing grade filtration (PDA TR No. 26), cleaning and disinfection programs (PDA TR No. 70), Manual Aseptic process (PDA TR No. 62), EU GMP guideline (Annex- 1), USFDA Guidance (Sterile Drug product), Health Canada, Code of Federal Regulation (CFR) and Contamination control strategy.I am approved and certified for the production technical from Daman FDA and, have undergone external training, and am certified as an Internal Auditor. I am awarded as a star employee for extraordinary contribution to the MHRA audit and its compliance and successful implementation of the Contamination Control Strategy in view of EU GMP guidelines (Annex 1).Proficient in SAP, Caliber QAMS (Quality Assurance Management System), Caliber DMS (Document Management System), EDMS, Learning Management System (LMS), and Minitab Software, I am well-equipped to navigate complex technological environments.