职位描述
岗位描述
Responsible for Hypak environment and product contamination control and support sterilization assurance activities within the plant to meet quality; service level.
工作职能：
Responsible for Hypak product and environment contamination control.
Responsible for GMP behavior establishment for all employee
Support to set up safety operation guideline for sterilization. Responsible for the safety procedures are strictly followed. Periodically review safety procedure to improve safety;
Support to define, plan and execute validations and revalidations of sterilizations according to established planning；
Responsible for sterilization daily work，review sterilization；
Maintain sterilization SOPs. Ensure all SOPs are strictly followed;
Control the execution of validations performed by vendors；
Manage Supplier Quality Assurance activities with the plant and with sterilization vendors and sub-contractors (technical agreements management, audits, technical deviations handling, investigations, complaints, customers’ visit at vendors…)
Leading or participating six sigma, lean, and validation activities;
Provide training to other associates on sterilization technologies;
And compliance WW/AP requirement on EO site.
Take responsible for related data trending analysis.
Escalate deviations
Manage CAPA related to sterilization activities
Participate to internal or external audits.
Performs any other task(s) as assigned, or defined in related quality procedure.
基本技能：
Good oral and written communication skill in English;
Possess strong leadership skills, excellent written and verbal communication skills and the ability to interact well with internal and external customers at all levels
ISO 111135 Sterilization of health-care products — Ethylene oxide —Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 14001 and OSHA 18001 Environment management system and Occupational health and safety management system
Good interpersonal skills with a demonstrated ability to develop and maintain a team environment;
Strong safety sense.
Logical approach to problem solving and troubleshooting.
Background in laboratory experience.
