QC Manager

YOUR TASKS AND RESPONSIBILITIES

• Leading Lab team to ensure QC operation & project activities compliance NMPA and Bayer standards to contribute site operation needs and strategic objectives. Lab operation activities main covering sampling, testing, documentation, reference standard & regents, environment monitoring, stability study, retention sample management, qualification & validation, instrument/equipment/environment  maintenance, etc. via documentation review and/or approval, system batchwise and periodic system/data review, as well as shopfloor coaching & oversight. 
• Leading Lab team delivery high performance target and reducing testing lead time beside high-level IR & low-level risk occurrence, excellent PDCA to reduce relative resource limitation, Lean project  Management, and drive focus delivery on site strategy focus GMP, PSS, SHE and cost areas and knowledge enhancement.
• Systematic implement PSS to drive "0 loss" culture, Rigorous testing behavior, problem systematic fix and proactive prevention improve do thing right @ the first-time capabilities and technical capability  maturity. 
• Establish and implement talent develop pipeline program, inspire high engagement, learning & sharing culture, training & workshops, SMEs development & qualification, Inspire & empower young talent to develop, transported workload & performance management, recognition, etc. 
• Leading team to screening, standardization, and optimization lab areas SOPs & records to enhance knowledge management and stabilize testing & working process to drive sustainable improvement. 
• Implement initiatives and/or programs to maintain healthy working environment, implement global and/or local digital initiatives and/or projects to enhance modern working place and paper less lab operation. 
• Implement loss analysis & assessment in terms of quality (OOS/OOT/Deviation), safety (event, first aid,) to ensure root cause founded, appropriate CAPA are defined and implement effectively in  cooperation with QA and/or SHE. 
• Drive quality management maturity and improvement with participating following activities: supplier management, change management, self-inspection, GEMBA, complaints lab investigation, HA Inspections, product registration and/or license renewal, product transfer, etc. 

WHO YOU ARE

• Education: Bachelor or above in chemistry/pharmacy or other related areas .
• Language: Fluent in communication with English (oral and writing). 
• Experience: More than 10 years working experiences in Quality Assurance/Quality Control actual experience in pharmaceutical industry, good understanding of operation optimization and change management 
• Preferred to have working experience in multinational company. 
• At least with 3 years team management experience, good understanding of team leading & development. 
• In-depth knowledge in Chemistry, pharmaceutical analytical technologies, local and international GMP regulations. 
• excellent understanding of QC lab operation and project management, as well as good understanding of new technologies and digital. 
• Excellent leadership, skilled communication, strong courage, excellent team work, open minded & business mindset concept.