About Us Services Capabilities Facilities Careers News Notices Contact Us Quality Home I About Us I Overview I SHE I Quality Development In SK biotek we are committed to sustaining a culture where all our colleagues demonstrate a personal commitment and ownership for product quality and regulatory compliance excellence. With many years of regulatory inspection, experience within the SK biotek network our teams of quality professionals interface successfully with multiple regulatory inspection agencies across the globe such as:The range of analytical services include analytical method development, validation and transfer. Analytical activities are performed in compliance with GMP and ICH guidelines. We strive to provide our customers with robust analytical methodology but pride ourselves on providing innovative alternatives. U.S. Food and Drug Administration (FDA); Japan’s Pharmaceuticals and Medical Device Agency (PMDA); Korean Food and Drug Administration (KFDA); Russian Inspectorate; European Medicines Agency (EMA); ANVISA. Quality and Regulatory Excellence Strategy Fundamentally our Quality and Regulatory Excellence strategy can be described under three key foundational principles: Operations Quality We operate as an integrated global quality network where we leverage the combined experience and talents of our global organisation to proactively address: issue resolution and product quality excellence, underpinned by a quality management systems grounded in a common set of standards and policies. Compliance Excellence We strive to ensure compliance in all our activities with the expectations and requirements of multiple global regulatory agencies. Validation of our regulatory compliance excellence is achieved through successful regulatory and customer inspections. Our quality management system strives to proactively reflect new and emerging regulatory requirements as we recognise regulatory compliance is continually evolving. Culture & Leadership We value everyones contribution in driving continuous improvement within our quality system and recognise that quality and compliance excellence throughout our entire organisation is owned and delivered by all our colleagues proactively doing the right activity, in the right way, each and every time. Quality and Regulatory Excellence Compliance In SK biotek, the criticality of Quality and Regulatory Excellence Compliance is reflected in our organisation design. Within our organization Quality is centrally managed where site quality reports directly to the Global Head of Quality thereby assuring site quality independence. With this structure Quality is placed at level within SK biotek where it has the ability to inform and influence our overall company strategy. SK biotek Ireland CEO SK biotek Korea CEO Global Quality Head Head of Plant Site X Site Quality Head Site X Site Quality Assurance Lead Site Quality Control Lead Recognising that people are our greatest assets, we have built and sustained a highly-qualified and capable network of quality professionals within our Quality Control (QC) and Quality Assurance (QA) organisations through focused training on personal development and technical competency building. Quality Control Our Quality Control organisations are skilled in the implementation of complex methodologies using techniques such as: Gas Chromatography (GC) & Gas Chromatography/Mass Spectrometry (GC/MS); High-Performance Liquid Chromatography (HPLC/UPLC); Liquid Chromatography/Mass Spectrometry (LC/MS); Ion Chromatography; Inductively Coupled Plasma Mass Spectrometery; Fourier Transform Infrared (FTIR)- Ultraviolet- Visible Spectroscopy (UV-VIS)- Polarimeter; Particle Size Analysis – Mesh & LASER; Differential Scanning Calorimetry (DSC)/Thermogravimetric Analysis (TGA). We recognise the criticality of electronic raw data and have optimised our automation tools such as LIMS, CDA and data archive solutions within our laboratories to meet the data integrity expectations of 21 CFR Part 11 in a compliant and robust manner. Quality Assurance Our Quality Assurance organisations are skilled in the implementation of quality systems using QMS software for investigation, change control and CAPA management. Quality Risk Management tools are also an integral part of the quality system implementation. In addition, our Regulatory organisation is experienced in the preparation of regulatory submission documentation in paper CTD or electronic CTD formats consistent with the requirements of global regulatory agencies. 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