上海招聘

POSITION: Senior In-process QA
岗位名称：高级中控QA
DEPARTMENT: Quality Department
部门：质量部
DIRECTLY REPORT TO: Quality Header
汇报对象：质量负责人
LOCATION: Shanghai
工作地点：上海

GENERAL DESCRIPTION概述
1. Monitor the whole production process including manufacturing and packaging to ensure that all activates are in compliance with requirement of GMP, Master Manufacturing Document and other related written procedure.
监控整个生产过程（包括生产和包装）以确保生产操作符合GMP，主生产记录及其他相关规定文件的要求。
2. Conduct batch release documentation to ensure its compliance.
审核批记录以确保其符合性。
3. Technical documentation transfer to contract manufacturer.
生产工厂技术文件的转移。
RESPONSIBILITIES / ESSENTIAL FUNCTION 责任/基本职责
1. In-process monitoring and checking for critical steps and/or parameters, line-cleaning/clearness, storage for semi-finished product, test result both for semi-finished product and finished product, packaging quality etc. Based on the approved procedures, specifications and work experiences analyze and make decision on whether the in-process products meet the requirements.
负责关键步骤和/或参数、生产线的清洁/清场、中间品贮存、中间品/成品的测试结果、包装质量等方面的监控和审核。根据获准的程序、规格标准以及自身的工作经验，分析并确定中间产品质量是否符合要求。
2. Be responsible for sampling in-process products or finished products during manufacturing products, if need.
如需要，在产品生产期间，负责半成品或成品的取样工作。
3. The joint responsibility of checking and releasing raw materials, excipients, packing materials.
参与原料、辅料及包装材料的审核放行。
4. Joint releasing the approved in-process finished products and finished products.
参与检验合格以及生产过程检查合格的中间产品及成品的审核放行。
5. Review the batch production records ensure its compliance. Report any problems during review in a timely manner to the Quality Header for final decision and batch disposition.
审核批生产记录确保其符合性。审核中的问题即使报告给质量负责人，以便做出最后的决策。
6. Inspection of the delivery ship of product to ensure the ship condition and hygiene complies with requirement.
负责产品货运检查，以确保货运条件和卫生符合要求。
7. Assist to the contract manufacturer to solve the problems during production and testing, and communicate them with the Quality Header in a timely fashion.
协助代工工厂解决在生产过程和检测过程中发现的各类问题，并及时跟质量负责人沟通。
8. Participate in deviation investigation and handling, including analyzing the cause of deviation, forecasting the consequence(s) and make comments to the corrective action plans, especially to the deviations of the quality of in-process products.
参与偏差调查，包括分析偏差产生的原因，预测结果，并对整改行动计划提出意见，尤其是对中间品质量存在偏差的情况。
9. Participate in the quality related complaints investigation.
参与客户质量投诉的处理。
10. Recommend the corrective actions and preventive actions plan on quality related discrepancy, track and evaluate the effectiveness of their implementation.
提议质量相关的偏差事件的CAPA计划，跟踪并评估其实施效果。
11. Conduct training to the relative staff of contract manufacturer respecting to the production and quality of the Beauty products.
负责代工工厂与Beauty产品生产和质量相关的培训。
12. Maintain all the site quality records for Beauty products, such as deviation report, change records, and records of rejection, return goods and recall, etc.
维护好Beauty产品的所有现场质量记录，如偏差报告，变更记录，以及不合格品、退货和找回记录等。
13. Participate in the transfer of technical documentation relating to production and quality, such as master formulation, process instruction, and specification.
参与生产和质量相关的技术文件的转移，比如处方、工艺规程、质量标准等。
14. Maintain the transferred technical documentation in current version.
维护转移的技术文件为当前有效版本。
15. Participate in developing, updating and revising documentation relating to his or her area.
参与工作领域中相关文件的起草、更新和修订。
REQUIREMENTS / QUALIFICATION岗位要求/条件
1. College degree or above major in pharmaceutical, chemistry or related. More than 3 years related experience.
大专或以上学历制药、化学或相关专业，有3年以上相关工作经验。
2. Familiar with the production procedure of tablet, hard shell capsule and softgel.
熟悉片剂、胶囊剂和软胶囊生产流程。
3. Be familiar with GMP, regulations regarding medicine or health food.
熟悉GMP，及药品或保健品相关的法规。
4. Basic computer skills, Word, Excel, Power point etc..
良好的计算机操作能力，熟练操作Word、Excel, Power point等。
5. Good communication skills.
良好交流技能。
6. Good problem solving skills.
善于处理各种问题。
7. Ability to adapt to rapidly changing circumstances internally and externally.
应有较强的适应内外瞬息变化环境的能力。
8. Initiative, innovation and judgement skills.
应具有主动性，创新，判断的能力。

达励雅公司是由挪威人投资的保健品贸易公司，从事中成药、植物萃取类的片剂和胶囊出口业务，在欧洲设有销售部门，上海公司现有20多人。
今年来，公司业务和规模不断增长，特邀请有志之士加盟。