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Company name Asset Engineering Recruitment Ltd
Category Information Technology
Contract Contract/Freelance
Full/Part time Full time
Description

Computer System Quality Team Lead Responsibilities;- * Act as Computer System Quality (CSQ) representative for functional areas, provide daily CSQ oversight and guidance, and ensure implementation. * Owner of one or more elements of the global Computer System Quality System (CSQS), maintaining and working with CSQS owner to improve the elements. * Specific responsibilities include: * Work with site CSQ Team to establish and implement local Computer System Quality and compliance procedures * Make contributions to continuous improvement of CSQS by gathering and analyzing feedback from business areas, and sharing feedback with CSQS owner and CSQ group * Establish effective communication with responsible functional area(s) and other global functional areas such as Automation & Information Systems (AIS), Engineering (ENG), and Process & Engineering Validation (PEV), and provide Quality Oversight and service in the areas related to computer system validation (CSV) and IT compliance with regulatory requirements, CSQS, and industry best practice. * Apply risk-based approaches in daily quality work, and ensure computer systems in responsible areas are validated prior to go-live, and stay in continuous validated status throughout the life cycle of the system * Conduct daily CSQ operation tasks: review/approve CSV documents, ensure CSV conducted properly, approve Computer System Incidents, Deviations, and CAPAs, coordinate computer system access roster review and periodic review, and so on and so forth. * Work with CSQ supplier management process owner to ensure computer system suppliers are properly assessed/audited before being used, and managed throughout usage. * Assist internal and external audits and regulatory inspections. * Guide junior members in site CSQ team. REQUIREMENTS: * 6-10 years of work experience, at least 3 of which must be in life science industry and in areas related to computer system quality (CSQ, ITQ, Software Quality, CSV, etc.) * Degree or above (maj

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