北京招聘

Job Purpose:
Responsible for technology transfer activities at site level, including any scale-up.
Leads technical transfer project team at site and liaises efficiently with involved functions (e.g. Development, Supply Chain, Production Unit, Quality Control, HSE, other sites.).

Responsibility:
? Manages technical activities on site level for product transfers (process, technology, analytics, capacity, resources).
? Provides technical expertise together with site experts.
? Defines and monitors project scope, timing and progress.
? Initiates change control in system and ensures approval and closure.
? Writes Manufacturing Process Transfer Documents (protocol, report).
? Coordinates feasibility, regulatory and validation batches at site.
? Initiates monitoring and Continued Process Verification CPV phase.
? Ensures that all activities are performed to current standards (current Good Manufacturing Practices cGMP, Health Safety Environment HSE, Regulatory etc.).
? Manages technology transfers for scale-up, at site level.
? Supports continuous process and quality improvements.
? Ensures inspection (Pre Approval Inspection PAI) readiness.

Pharma operation - 北京诺华制药有限公司 北京昌平制药工厂诚聘