M&S-Sterility Assurance Lead-Beijing
Core
Lead sterility assurance and microbiological programs to ensure product safety and compliance in a global healthcare manufacturing environment.
Role type
Senior IC sterility assurance lead (manufacturing)
Builds
Safe, sterile pharmaceutical products for patients
Domain
Healthcare manufacturing / Sterility assurance
Required skills
Sterility assurance strategy, Microbiological program management, GMP compliance, Validation and qualification, Risk mitigation, Team leadership, Regulatory inspection preparation, Continuous improvement, Contamination control strategy (CCS), Environmental monitoring
Preferred skills
Change control assessment, Clean zone re-construction, Cross-functional collaboration, HSE management
Technologies
GMP, cGMP, Pharmacopeia, HSE systems
Responsibilities
Develop and implement comprehensive sterility assurance and microbiological programs; Ensure compliance with regulatory requirements and company quality standards; Oversee production activities and aseptic practices; Lead management reviews and team performance; Prepare for regulatory inspections and audits; Drive continuous improvement initiatives; Support contamination control strategy implementation; Investigate sterility/microbe contamination issues.