Head of Quality Assurance Operation Unit (APU) & Sterility Emplois

Description du poste

Nos équipes produisent et livrent chaque année plus de 4 milliards de médicaments et de vaccins, veillant à ce que chaque avancée soit accessible à ceux qui en ont le plus besoin. Grâce à des infrastructures ultra-modernes, des usines intelligentes pilotées par l'IA et une automatisation de pointe, nous repoussons les limites pour garantir que nos traitements parviennent aux patients plus rapidement, en toute sécurité et de manière plus durable que jamais. C'est ici que votre expertise, votre ambition et votre passion peuvent façonner l'avenir de la santé.

Responsabilités

Assist site quality head to ensure that product is manufactured and controlled under cGMP condition and marketing authorization
Develop quality system to be in alignment with local cGMP, industry standards, regulatory expectations and Sanofi requirements
Keep on developing the quality system and establish or update the related SOP according to the global quality standard / cGMP and other local requirements together with other departments
Ensure the cGMP compliance of the calibration, utilities, systems, production processes (raw materials, in process product, finished products) and control procedures
Make decision of batches, materials and quality event in compliance with the registered specifications and cGMP requirements
Review the batch manufacturing / packing master records and review the annual products quality
As the Lead of operation QA to respond to operational business
Establish procedures and ensure continuous improvement of the PCU quality oversight and GMP documentation
Provide quality assurance oversight by performing routine walk-throughs and inspections on production, laboratory, warehouse, engineering deportment and other areas assigned
Ensure the plan in place
Manage procedures to correct deviations and out of specification (OOS) results and monitor the corrective and preventive actions (CAPA)
Support CAPA implementation and review CAPA effectiveness
Evaluate the change control related sterile and non-sterile manufacture and follow the execution
Act as the final evaluator of change quality and sterile assurance to ensure changes are properly evaluated
Support and participate project or improvement of products and product launch and technical study
Evaluate suppliers relative to sterile operation
Participate self-audit, global audit and regulatory inspection to improve the site GMP compliance
Establish and assure a continuous GMP training to maintain an high level of GMP awareness in all the staff
Lead the complaints investigation related to sterile and non-sterile products in Beijing Site
Ensures quality risks are properly managed (identification, assessment, control, communication)
Play a key role as site microbiology contamination control expert to ensure the manufacturing system and quality control system fulfil the regulatory, quality and technical requirements
Establish a robust contamination control strategy and sterility assurance system
Provide technical proposal on clean zone re-construction, optimization process, utility control, and environmental monitoring from sterility assurance perspective
Trouble shooting for sterility issues in Process, Equipment, Utility, testing, material
Deploy technical training in site level and implement the CCS regarding the sterility assurance
Manage sterility assurance related projects
Participant the establishment of recall process and recall activity
Manages the QA team under his/her responsibility with respect to all applicable rules
Perform people performance management
Make individual develop plan with personnel within QA team and build up technical ladder
Ensure oversight and perform activities related with Medical Device according to the current Good Supply Practice (GSP) regulations
Ensure CMO quality system management when Beijing site as MAH

Exigences

5+ years' experience in quality control and/or quality assurance
3 years management position
3 years of experience in sterility assurance and microbiological control in the medical device, pharmaceutical, biotechnology, or related industry
Good communication
Able to burden pressure
Think strategically
Make decisions
Good leadership
Must be a committed 'quality' professional with knowledge of regulated quality systems within the pharmaceutical or related industry
Knowledge of analytical chemistry and microbiology
At least a bachelor degree in pharmacy or chemistry or biology disciplines
Good English verbal & written communications

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Head of Quality Assurance Operation Unit (APU) & Sterility

Description du poste

Responsabilités

Exigences

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