Computer System Quality Senior Specialist
* 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.
* 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 (majored in IT) or other fields (with good understanding of IT)
* Experience with Software Development Life Cycle (SDLC)
* Expertise with quality requirements of all stages in SLDC
* Excellent communication skills, particularly cross-function communication
* Good balance between having team spirit and working independently
* Familiar with questions and challenges in audits and regulatory inspections
* Demonstrated passion for Computer System Quality field
ADDITIONAL POSITION SPECIFIC DUTIES/INFO
• Certification with Quality Organizations preferred
• Certification with Regulatory Agencies (FDA, EU, WHO) preferred
• Team leader experience ideal