Panel discussion
Thursday, July 18
05:30 PM - 06:30 PM
Live in Singapore
Less Details
This panel convenes esteemed industry leaders, and MES authorities, to underscore the imperative of Manufacturing Execution Systems (MES) in fortifying compliance, operational efficiency, and data veracity within (GMP) environments. Central to this discourse is the emphasis on strategic planning and the deployment of MES, defining and monitoring successful implementation Key Performance Indicators (KPIs), advocating for a ‘doing it right the first time’ ethos as the cornerstone of any MES project strategy. The conversation will pivot to the strategic design of digital processes to foster reusable elements, thereby expediting organizational scaling and the seamless onboarding of new processes.
ISO QMS 2000 Lead Auditor , IRCA Certified Provisional Auditor for ISO 9001: 2008 . Quality standards ISO 17025 awareness program.
Currently working as head QA, Ext. mfg.
Managing Quality compliance at CMO, team building, regulatory compliance, successful completion of regulatory audits
Responsible to ensure that quality systems are followed for every batch and every product manufactured at the subcontracting sites for both types of business arrangement (Toll (LL) and Full (P2P) manufacturing).
Managing the training needs of the management employees of the EM sites at the sites on Quality, Safety, Hygiene and other aspects of their skills for further development. Preparing and sharing the training modules for sites.
Managed all dosage forms injectable, tablets, capsules, cream, ointment and liquid orals manufactured by CMO. knowledge of Animal Health Care products and animal Feed Additives products for Domestic and export market. Handling export products for EU, Russia, CIS, Ukraine, Latam, Sub- Sahara markets.
Discussing and resolving quality related troubleshooting and taking release/reject decisions along with global heads. Participate in strategy building, due diligence and acquisition projects.
I am career-focused, highly self-motivated and hard-working, with strengths team-work, communication skills, problem solving, to handle challenging tasks, think strategically and use innovative solutions, simplification of work. My strong work ethic combined with my passion and dedication has helped me to reach my goals. I believe to utilize my skills and abilities to learn and grow professionally.
Hyeog June is a Project Manager and Specialist(especially MES) at DONG-A ST. In this company, he is responsible for everything from the OT to IT system of the ISA 95 model. As a project engineer, he has experience in building GMP OT/IT system in brownfield. As a project manager, he has experience in building GMP OT/IT system in green field(e.g. MES, WMS, SCADA). Prior to DONG-A ST, Hyeog June was in charge of production technology engineer at LG Chemistry and a data center's embedded system engineer at NAVER CLOUD.
Skilled in System Process Design&Development, Interface and Integration Management between systems(IT-IT, OT-IT, OT-OT), Network Infra & Cloud Management, GMP OT/IT system management(e.g. Security, CSV, Audit trail, Privilege and Back-up&Recovery). Also engineering all of these. Working as the only system administrator at the unit factory.
Brix Bayuga is Senior Manager Global Regulatory Affairs (CMC/Strategy) at Pfizer, where he has worked for more than 12 years. He has more than 16 years of professional experience in dealing with Health Authorities globally, expertise in authoring dossier submissions (new submissions, lifecycle management, BOH responses), developing and executing regulatory strategies, and compliance, as well as a hands-on operational experience working with manufacturing sites.
Chandrakant Dube has master’s degree in microbiology from Pune University India. He is currently working on a Global Role, part of Fresenius Kabi Pharmaceutical Division Quality Management in Global Competence Center Microbiology & Aseptic Techniques, where he is mainly dealing with Establishing global standards, on- and off-site training concepts, hands on - training, guidance/advice, and support in the area of Microbiology and Aseptic Techniques for all Fresenius Kabi’s Pharmaceutical manufacturing plants, focusing on Asia/India region. He is having diverse experience in API manufacturing, Probiotics-Biotechnology & Sterile Aseptic Processes.
His greatest motivation is the constant flow of challenging projects that he is dealing with globally and working with the International team members across the Globe.
The Pop in your Job:
I love to work with colleagues from different part of the world in order to improve the system/process within our organization. I am happy that I can contribute, grow and become a better version of myself.