上海招聘

Responsibilities of this position:
1. maintaining and improving of validation system
2. Develop the SOP related to equipment, system validation
3. Develop the User Requirement Specification (URS), Validation Plan (VP), Risk Assessment (RA) and Validation Summary Report (VSR) for the Computerization System Validation (CSV) in compliance with the requirement of FDA and CFDA.
4. Create the qualification plan, test protocol for system Installation Qualification and Operational Qualification
5. Perform the execution of qualification protocol and the maintenance of validated equipment
6. Communicate with equipment vendor for technical support
7. Record and handle the deviation occurred during the validation/calibration
8. Provide validation and SOP training
9. Periodically review the validation document for the equipment in GLP lab so as to maintain the validated status

Qualification:

1. Bachelor degree or above in engineering, pharmaceutical or related
2. Experience: More than 1 year experience in the field of validation, GXP environment
3. Be familiar with pharmaceutical equipment, LIMS, environment monitoring system
4. Good spoken and written English skills
5. LIMS, bioanalytical instrument experience is a plus

康龙化成新药技术股份有限公司成立于2004年，是国际领先的生命科学研发服务企业。经过多年发展，康龙化成打造了全方位的临床前药物研发及临床开发一体化平台，贯穿合成化学与药物化学、生物、药物代谢及药代动力学、药理、药物安全评价、放射标记代谢、工艺研发、GMP生产及制剂研发临床试验及临床样品的分析服务等各个领域，提供包括苗头化合物探索与靶标验证、先导化合物优化、临床前候选药物筛选、临床候选物的确认及临床开发、新药临床研究申请和新药申报等一体化研发服务。康龙化成在中国、美国、英国均有运营实体，全球员工人数15000+，业务遍及全球，服务客户包括世界前20大医药公司在内，已超过1500家。