Key Responsibilities Responsible for routine quality oversight for DP manufacturing areas to ensure all GMP activities including aseptic filling, lyophilization, visual inspection, and packaging are executed based on SOPs and related procedures. Responsible for the review of DP manufacturing processes documents including but not limited to PFD, BOM, MBR to ensure the compliance with regulation and company procedures. Responsible for executed batch record and e-data review and quality implementation. Responsible for DP manufacturing related SOPs review. Responsible for the deviation investigation, product complaint and change control assessment. Support ****** and regulatory audit and inspection. Participate in DP manufacturing area related quality trending analysis and improvement. Qualifications: Bachelor’s degree or above in a relevant field (e.g., Biology, Chemistry, Pharmacy, Engineering) or equivalent experience. At least 5 years of experience in a QA, DP production or DP MSAT role within the biopharmaceutical industry. Good experience and knowledge in aseptic processing and sterility assurance, as well as DP process validation. Familiar with FDA, EU, NMPA GMP and other technical guidance i.e. PDA report for aseptic product. Ability to work effectively in a fast-paced, dynamic environment. Good English reading and writing, great for English speaking.