This position is for Suzhou Wuxi Vaccines.（药明海德） Job Responsibilities: 1. Production management 85 Plan, organize, and supervise daily manufacturing operations for solid dosage forms (tablets, capsules, powders) or liquid formulations. 85 Ensure adherence to production schedules, batch records, and SOPs to meet delivery timelines. 85 Monitor yield, efficiency, and equipment performance, implementing corrective actions as needed. 2. Quality & Compliance 85 Enforce strict compliance with cGMP, FDA/EMA/ICH guidelines, and company quality systems. 85 Investigate deviations, and CAPA (Corrective and Preventive Actions) in collaboration with QA. 85 Participate in internal/external audits and regulatory inspections 3. Team Leadership 85 Coach team members to establish personal development plan & annual performance goals, and provide continuous tracking and feedback. Pay attention to personal development needs and establish a good team atmosphere 85 Identify high-potential employees, develop SME and shift leaders，establish flexible shift system; 85 Be responsible for the maintenance of team organizational structure and personnel recruitment, ensure that the personnel development is in line with the post needs, and improve the enthusiasm of personnel 4. New product 85 Be aware of the manufacturing part during new product introduce. 85 Be familiar with the SUS, filter design and PPM selection. 85 Have a good ability to build up the good cooperation ship with MSAT, QA, QC, SC and SEM, etc. 5. Equipment & Facility 85 Oversee maintenance, calibration, and validation of production equipment. 85 Ensure cleanliness and compliance of the production area. 6. Documentation & Reporting 85 Review and approve batch records, logbooks, and production reports. 85 Prepare KPIs and present operational performance metrics to senior management. Requirements: 1. Bachelor’s/Master’s degree in Pharmacy, Chemical Engineering, or related field. 2. The good pipeline project management is a plus. 3. 8+ years in pharmaceutical manufacturing (aseptic process manufacturing experience is preferred). 4. 3+ years in a supervisory role within a cGMP environment. 5. Fluent English speaking and good communication skills 5. Knowledge of FDA, EU, WHO, NMPA GMP related requirements 6. Be familiar with Microsoft office software for document handling such as Word, Excel, Power point, Visio etc. 7. Have the ability to use tools such as PSP to analyses and solve problems 8. Pro-active, high sense of responsibility, self-discipline 9. Production-oriented comprehensive working system, can respond at any time 10. Excellent communication, problem-solving, and organization skills, attentive, careful and meticulous, with strong team-work ability
