QC Support Expert

9 hours ago

Singapore AVENTIS PHARMA MANUFACTURING PTE LTD Full time

Transform Lives Through Excellence in Quality Control At Sanofi, we deliver 4.3 billion healthcare solutions to people every year, transforming the practice of medicine through breakthrough science that improves people's lives. Our Manufacturing & Supply teams ensure this impact through flawless planning and meticulous attention to detail. With your expertise in Quality Control, you'll help us protect more people from infectious diseases and bring hope to patients and their families worldwide.Your Impact As our Quality Control Support Expert, you'll be the cornerstone of laboratory excellence, ensuring compliance, efficiency, and continuous improvement in our quality control operations. Your expertise will directly contribute to patient safety and product quality through:Key Responsibilities: Equipment & Systems Management Ensure comprehensive lifecycle management of QC laboratory equipment Lead qualification and maintenance operations for QC equipment Establish metrics and monitor qualification activities to identify trends Ensure all QC equipment are properly qualified and maintained Serve as SME for Labware LIMS and collaborate with global functions Technical Leadership & Method Management Lead compendial compliance assessment and adherence for the QC laboratory Support annual method reviews within the product review framework Lead periodic analytical method control trend reviews and recommend improvements Support the invalid assay trending program in the QC laboratory Participate in Change Control Request facilitation for QC test methods Digital & Data Management Implement and maintain QC digital solutions (core and local models) Ensure proper documentation, review, and approval of qualification deliverables Record all required data and calculations in compliance with cGMP and Data Integrity requirements Provide technical system administrator support for QC GXP computerized systems Quality & Compliance Maintain site validation master plan and procedures related to ALCM and CPV Investigate and resolve quality control events promptly Provide support during regulatory inspections and audits Represent the site in Communities of Practice (CoPs) led by global teams Deputize as QC Manager when required Safety & Continuous Improvement Ensure compliance with HSE policies and site procedures Embrace Zero Incident Mindset and adhere to Life Saving Rules Lead initiatives for continuous improvement in QC support processes Practice and communicate laboratory safety standards What You Bring Strong chemistry background with technical expertise in laboratory equipment qualification and analytical method validation Experience with LIMS and laboratory computerized systems Knowledge of cGMP, data integrity requirements, and regulatory standards Excellent problem-solving skills and attention to detail Strong communication and collaboration abilities Commitment to quality, safety, and continuous improvement Why Join Us? Join our team and be part of a mission that matters. At Sanofi, you'll have the opportunity to grow professionally while making a meaningful difference in patients' lives. Your expertise in quality control will directly contribute to our ability to deliver safe, effective healthcare solutions globally.

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