QA Operation

Responsible for overseeing manufacturing, testing and validation activities, ensuring compliance with internal procedures and regulatory requirements. Responsibilities: • Oversee routine quality control for on-site GMP production and testing, ensuring all GMP activities are executed in strict adherence to company procedures. • Contribute to the establishment of an effective quality system and ensure its efficient operation across all GMP functions and processes in daily operations. • Provide quality oversight for validation and re-qualification activities, ensuring validation status is consistently maintained • Accountable for QA Review of all Qualification and Validation protocols and reports, including computer system validation. • Ensures that the data integrity of all documentation and electronic data complies to all application regulations and SOP requirements • Participate in site operational readiness programs, including self-inspection and data integrity surveillance for GMP and client audits. • Manage quality events, including deviations, change controls, CAPA, and lab investigations etc. • Carry out additional tasks as assigned by leadership. About You: • Bachelor’s degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or other relevant fields. • At least 1-3 years of relevant QA experience in Biopharma or Pharmaceuticals for Junior role & 3-5 years of experience for Senior role. • Familiar with FDA, EMEA, and PICS GMP requirements. • Knowledgeable in biological product manufacturing and related quality control requirements. • Experience in biopharma commercial supply is preferred. • Experience with a new site start-up is preferred. • Proficient in English listening, speaking, reading, and writing. • Skilled in Microsoft Word, Excel, PowerPoint, etc. • Strong learning ability. • Excellent cross-functional communication and collaboration skills. • Strong logical thinking and conflict management abilities. • Demonstrates strong ownership. Contract Period: 12 months