Sterile Production Specialist

• Assist dept. manager to coordination of Project, plan, Quality and engineering to organise production with right volume, right quality, right cost and on right time
• Supervise production, human resources, facilities to ensure all activities comply with China GMP and Sanofi regulations
• Keep continuously improvement in terms of safety, quality, cost, delivery, motivation and environment
• Continuously improve the compliance level of sterile production, attend and promote SMS execution, Lean manufacturing
• Organize, coordinate, track and implement of deviations, changes, validation, complaints and global standards gap analysis etc
• To ensure the continuous process compliance improvement through the management of quality systems
• To ensure the implement of quality policy/objectives of Sanofi and to ensure the quality compliance of sterile production operation
• To ensure effectiveness of sterile production quality improvement programs/projects
• Perform the job duties of the Inspection Process-Centric Unit
• Responsible for the shift work of PCU production (morning, middle and night)
• Participate in process optimization, equipment improvement and technique innovation to sustainably improve OEE and yield, participate in SMS standards deep execution and continuously improve in 5S/HSE aspects and waste minimization
• Optimize the production process, improve the equipment and system, consistently supply high quality production for commercial operation preparation
• Sustainably improve yield of compounding, filling and inspection equipment and ensure the stable supply to the market
• Management of the production environment, process, hygiene, facilities to make sure all production activities comply with drug master file, SOPs and GMP requirements
• To review the batch production records and submit to Quality in time
• To implement the equipment qualification, process validation according to the master plan
• To execute and follow the required initial and continuous trainings of production operators
• Organize daily production meeting, coordinate all shifts and keep closely communication with planning, QA, maintenance and warehouse etc., to implement production plan strictly and ensure right Plant Service Level and Bias
• Follow up the actions of Change Control, CAPA for deviations or complaints related to production
• Develop necessary SOPs and ensure the implementation and improvement
• Implement SMS standards and continuously improve in 5S/HSE aspects and waste minimization
• Report product complaints and adverse drug reactions according SOP requirements
• Other tasks temporarily assigned by department manager
• Responsible for following the company’s HSE policy and integrated all requires into daily job
• Incorporate HSE work into the work plan
• Organize the implementation of HSE management target plan of this department, implement HSE rules and regulations, HSE operation procedures and HSE technical action plan
• Regularly carry out to identify HSE potential hazards and develop action plan and finish on time
• Timely working out of employee opinions
• Actively cooperate with HSE management to prevent accidents happens
• Regularly carry out +QDCI meetings at all levels considering HSE8 requirements. Feedback HSE issues in a timely and accurate manner, and actively implement remediation
• Participate in the investigation for accidents, analyze the root causes of accidents from the quality management perspective, and related CAPA
• Responsible for design annual department PASS plan and ensure implementation as planned
• Actively propose energy-saving projects
• Coordinate and support the development of energy-saving projects and give positive feedback
• Coordinate and participate in the implementation of energy-saving projects
• Participate in internal audit of energy management system

• At least a bachelor or above degree in pharmacy or biology disciplines with 0~2 years’ experience in quality or sterile area
• Must be a committed "Quality or Sterile" professional with knowledge of quality systems within the pharmaceutical or related industry
• Thorough understanding of manufacturing processes and aseptic processes
• Strong working knowledge of quality systems, regulatory requirements across multiple health authorities
• Fluent English both in written and verbal
• Good communication skills
• Able to burden pressure
• Brave to make decision

high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave