职位描述
职位描述: Responsibilities:1.Draft procedure and report of equipment/instrument qualification.2.Perform the execution of equipment/instrument qualification.3.Coordinate with ENG department in terms of validation instrument calibration.4.Responsible for validation/qualification annual review, requalification, deviation, change control, investigation, CAPA, and/or the other GMP activities related to facility, equipment and cleaning. Able to write change controls, deviations and CAPAs in a logical and clear manner and follow up progress.5.Support in process/analytical method/cleaning validation coordinating with other related department/team.6.Prepare monthly/weekly summary report for equipment/instrument qualification related activities.7.To communicate with and assist different group or department in a timely manner to fulfill the work assignment with efficiency.8.Conduct the work assignments in compliance with cGMP regulations whenever applicable.Qualification:1.BS degree in chemical, mechanical, electrical engineering or equivalent practical working experience.2.A minimum of two years GMP experience in a biotech or sterile pharmaceutical manufacturing environment.3.Knowledge of cGMP requirements.4.Knowledge of validation test instruments such as Kaye, Fluke, TESTO, and air sampler.5.Knowledge of facility engineering/design such as HVAC system, clean facility is a plus.6.Solid experience in process/analytical method/cleaning validation is highly preferred.7.Proficient in computer skills and MS Office applications.8.Excellent written and verbal communication skills.9.Excellent written and spoken English communication skills is preferred. 职能类别: 生物工程/生物制药 药品生产/质量管理