PharmSol集团招聘,含医学翻译

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企业简介:

PharmSol集团于2004年成立于迪拜,是一家医药科技有限公司,业务领域覆盖整个医药行业的各个环节,包罗:厂房设计、产物开发及外包(技术转移)、合规指导、质量审计、药政注册、产物上市等等。目前七家子公司遍及全球,包罗欧洲、亚洲以及中东地区,此中,法索(南京)医药科技有限公司于2019year1月在南京设立,旨在为国内制药企业提供量身定制效劳,从而满足国内药企对于欧盟、美国、澳大利亚、WHO(世界卫生组织)等不同官方法规的要求。此中以第三方名义停止GMP / QP 审计、协助国内药企获得欧盟 GMP 认证、仿制药一站式技术转移、协助应对美国 FDA 查抄方面成功经历尤为突出。

招聘岗位:

药学英语翻译2名:主要翻译客户消费的成品制剂(片剂、胶囊、注射剂)OfGMP文件。

质量专员2名:主要负责国内项目的法规事务和合规效劳;项目包罗核查/审核/翻译客户消费的成品制剂(片剂、胶囊、注射剂)OfGMP文件,以符合美国FDA、欧盟GMPandTGA的要求;及协助经理停止现场GMP审计。

制剂研发2名:负责前期中英对照文件的筹备,例如:方案、批记录、验证陈述、技术包、主配方表、研究方案等。

消费技术岗2名:负责方案和施行技术转移;评估阐发数据和不变性数据;文件筹备,例如:质量尺度,主配方表,批消费记录,技术包。

项目助理2名:前期中英对照文件的筹备;在外国专家的指导下完成方案和施行技术转移。

Requirements:

药学、化学及相关专业本科以上学历,英语好优先。

薪资:面议

福利待遇:五险一金、节假日礼品、定期体检、通讯补助、培训等。

上班时间:周一至周五08:30-17:30

公司地址:江苏省南京将来科技城4Building 1R402

简历投递:feronica@pharm-sol.com

The Company

PharmSol is an integrated pharmaceutical services company primarily focused on generic pharmaceutical businesses in Europe and now also expanding its reach in US. PharmSol has headquarters in Dubai with offices in Germany, Malta, China, Hong Kong and in India. Over the last 16 years, we have developed a long term, strong and reliable network of manufacturers in Asia for supporting our generic clients in EU and elsewhere. PharmSol is currently offering the following key services on integrated basis, and the service portfolio is fast expanding:

1. Product development, Tech Transfer of Formulation Mfg. from EU / US to Asian sites with complete assurance on quality, IPR, technology and supply chain management.

2. Development and sourcing of key APIs

3. Partnering in Generic Co‐developments for Europe.

4. Carrying out 3rd party GMP Audits on behalf of EU Generic companies.

5. Managing Supply Chain of products right from Asian Mfg. premises to the Distribution/Wholesale warehouse in compliance with EU GDP requirements with advanced security systems.

6. Hosting European Operation for non‐European companies and Mfg. partners from Asia.

7. Licensing and Registration of EU / US registered product in Asia and MENA region.

Location ‐ Nanjing, China.

Primary Responsibilities:

    Planning and execution of Tech Transfers.Evaluation of Analytical data and stability data.Documentation preparation, e.g. Specifications, MFC, Batch Production Record, Tech Pack.
Qualifications:

    Master’s Degree in Pharmaceutical Chemistry, Industrial Pharmacy or
similar

    Candidate must be able to understand and communicate in English language.At least 4‐6 years’ experience of working in pharmaceutical manufacturing workshops.
Skills:

Candidate with given skills would be highly preferred:

i. Experience in Manufacturing activities in Oral solid dosage forms

ii. Sound technical communication in both written and oral in English language.

iii. Hands on experience of working with pharma manufacturing machines.

iv. Experience in preparation and review of documentation (Protocols, Batch Records, Validation Reports) Tech pack, MFC, study protocols)

Work Environment:

• Adaptability to work flexible hours

• Travel to different location

• Location –Nanjing_China.

Remuneration:

Company provides an attractive remuneration package which also include bonus and allowances.

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点蓝字理解近期集训:

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second halfCATTI测验通关

LEC法律英语和法律翻译实训

我们的产物和效劳清单汇总(持续更新)

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