QC 理化分析研究员

will evolve based on project timelines, and may require candidates to carry out additional job functions not described in the job description but associated with the role. Essential Duties and Responsibilities Perform analytical method transfer, verification, validation and routine analysis using various analytical techniques; including but not limited to HPLC (Size Exclusion, Ion Exchange, Reverse Phase, Hydrophobic Interaction etc), GC, IC, CE, cIEF. Lead the preparation of analytical method validation documents and lifecycle management activities in compliance with GMP and ICH Q2(R2) requirements. Support activities including general lab readiness, audit readiness, laboratory equipment qualification, routine calibration and maintenance. Drive the establishment of required inventory for team and develop a system for stock control of laboratory consumables and reagents. Foster Operation Excellence and continuous improvement environment; including implementing Lean tools (5S, Kanban and Kaizen). Maintaining high Quality, Compliance and Safety system in a GMP Laboratory. Participate in various Lab deviation and investigation process such as OOS, OOT and atypical results, including the implementation of CAPAs and change control. General laboratory support such as housekeeping, and training support. Consistently delivering and monitoring specific Lab Key Performance Indicators. Experience Experience working in a Quality Control Lab or relevant GMP environment. Previous experience from Pharmaceutical/Biopharmaceutical using Chemistry analytical techniques; Liquid/Ion Chromatography, Electrophoresis and Spectroscopy. Strong understanding and practical application of ICH Q2(R2), analytical method lifecycle management, and method validation activities. Experience with Empower and LIMS or related system is desirable. Experience with Microsoft Word, Excel, and PowerPoint is required. Qualifications University degree with 3~4 years of working experience or Master‘s degree in related science/quality discipline with 1~2 years of working experience required. Behavioral Competencies Ability to work in a team environment and independently. Excellent written and reading English skills with effective verbal communication ability. Comfortable in a fast-paced working environment and able to adjust workload based upon changing priorities. Ability to think critically and demonstrate troubleshooting and problem-solving skills. Flexible approach to work and a positive attitude will be a good fit within the team dynamic. Engage cross functionally in conjunction with a site-based team. Autonomous and a self-starter who will use their initiative to drive actions forward. Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers’ expectations.

, validation and routine testing aligned with project timelines. As part of the project,