GM

Job Description : Gm sterile operations Vietnam Qualification: Bachelor's Degree in Pharmacy / Engineering ???? Experience: 18+ Years in Sterile Manufacturing & Aseptic Filling ? Key Responsibilities: ? Lead and manage aseptic manufacturing operations. ? Oversee filtration, aseptic filling, capping & sterile production processes. ? Troubleshoot filling machines, isolators, filtration systems & production equipment. ? Conduct smoke studies and implement process improvements. ? Ensure compliance with aseptic practices, gowning procedures & sanitization standards. ? Execute Media Fill Validation, Filter Integrity Testing (PUPSIT) & contamination control strategies. ? Prepare and review SOPs, Batch Manufacturing Records (BMRs) & GMP documentation. ? Support Equipment Qualification (IQ, OQ & PQ), Validation & Commissioning activities. ? Develop and train production teams to enhance operational excellence. ? Drive cGMP, Data Integrity, Quality Compliance & Regulatory Inspection Readiness. ???? We're Looking For: ? Extensive experience in Sterile Injectable Manufacturing. ? Strong expertise in aseptic filling technology and contamination control. ? Proven leadership, team development & people management skills. ? Hands-on experience in validation, qualification & regulatory compliance. ? Experience in equipment upgrades, vendor management & continuous improvement initiatives.

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