制剂生产车间验证工程师

岗位职责 Main Responsibilities
1.起草制剂设备验证方案和报告。
Draft the protocol and report for DP equipment.
2.起草清洁确认或验证方案和报告。
Draft the protocol and report for cleaning verification or validation.
3.起草工艺验证方案和报告。
Draft the validation protocol and report for the production process.
4.起草公用设施验证方案和报告，如水系统、洁净空调系统和压缩空气系统。
Draft the validation protocol and report for public facilities, such as water systems, clean air conditioning systems and compressed air systems.
5.起草制剂库房验证方案和报告。
Draft the protocol and report for DP warehouse.
6.起草计算机化系统验证方案及报告
Draft the validation protocol and report for the computerized system.
7.调查和评估验证中产生的偏差，并上报QA。
Investigate and evaluate the deviation in validation, and report to QA.
8.对工艺的变更做出评估。
Evaluate the changes of process.
9.完成其他相关工作。
Execute other related tasks.

任职资格 Qualifications
1.药物制剂、制药工程或相关专业专科或以上学历。
College degree or above in pharmaceutical preparation, pharmaceutical engineering or related majors
2.五年以上验证工作经验。
At least 5 years’ experience in validation work.
3.熟悉中国、美国及欧盟相关制药法规，如《中华人民共和国药品管理法》和GMP法规等。
Familiar with China, USA and EU the relevant pharmaceutical laws and regulations, such as “The Drug Administration Law of the PRC” and “Good Manufacturing Practices” etc.
4.熟悉制药行业相关指南，如ICH。
Familiar with pharmaceutical industry related guidelines, such as ICH.
5.具有制剂工艺问题分析能力及工艺验证设计方案能力。
Have ability to analyze drug production process problems, and process verification design protocols capability.
6.具有制剂生产设施和设备的验证能力。
Have the verification capability of drug production facilities and equipment.
7.具有执行清洁验证或确认的能力。
Have ability to perform cleaning validation or verification.
8.具有验证风险评估能力。
Have ability to risk assessment for validation.
9.具有独立解决产品工艺问题的能力。
Have ability to solve process problems independently.