职位详情
Missionpharma is a supplier of health care products to the public health sector in developing countries and to aid organisations worldwide. We are a global project-oriented organisation with the majority of our work being based on international tender business involving a great amount of cross-organisational teamwork.
The company is headquartered in Denmark with subsidiaries and regional offices in India, China and Africa, along with local representatives in more than 14 countries worldwide. Missionpharma has more than 150 employees worldwide. The office in Shanghai has existed for 15 years and currently employs five people within procurement and quality control.
QA Officer – Shanghai, China
QA主管—上海, 中国
As our QA officer in Shanghai, you will be responsible for carrying out Missionpharma’s QA operations within pharma, and maybe medical devices later, on the Chinese market, referring directly to our Director of Quality and Regulatory Affairs based in Denmark.
Area of Responsibilities:
Under the general guidance of our Missionpharma Quality Auditors to carry out QA/QC tasks and help to ensure a constructive dialogue with the Chinese manufacturers related to product range, GMP compliance and product file level.
Travel extensively in China around 70 days per year at various manufacturers’ facilities.
Maintain a dialogue with the manufacturer to help with the process of getting the needed documents available.
Collect and assess documentation and samples needed for product approval included but not limited to product questionnaire, product specifications, release criteria, stability studies and API certifications.
Help with taking the needed actions in case further information or documents are needed.
Visit our manufacturers representing Missionpharma as a part of a post audit visit to facilitate the progress in terms of quality related issues towards a manufacturer.
Co-ordination with suppliers and warehouses for transit inspections.
Ensure that customers’ claims/complaints are processed in collaboration with QA, Procurement and Sales department.
Various ad-hoc tasks.
Position requirements:
University degree in Pharmaceutical Science or related area (BSc or MSc).
+5 years related work experience from a QA, QC, production or regulatory department of a manufacturer of API or finished dosage forms preferably for the international markets.
Experience from an international or top Chinese company is preferred.
Hands-on experience with GMP related issues including SOPs, Stability, QA/QC and Manufacturing processes in the pharmaceutical and Medical Devices industries.
Excellent verbal and written technical communication skills in English and Chinese. Translation skills within Chinese/English and pharmaceutical technology.
Candidate Profile:
A strong team player with the ability to adapt to various cultural backgrounds.
Proactive, positive, detail oriented and efficient.
Ability to manage/prioritize multiple projects independently and in a structured manner.
Missionpharma offers:
An exciting and challenging position in an international company, where you will be surrounded by passionate people in our Chinese team, which plays a key role in our global sourcing operations. Our culture is informal, and the environment is young and dynamic, and you will be guaranteed a challenging job in which two days are never alike.
其他信息
语言要求:英语、普通话
行业要求:全部行业
公司介绍
DI-Asia Base Business Services Ltd.
DIAB assists Danish companies that seek international growth by developing their businesses in challenging markets in China. DIAB offers individual solutions on strategy, establishment, market analyses, comparative analyses, business plans, feasibility studies, financing, partner searches, and contract drafting.
DI-Asia Base Business Services Ltd. was established in Shanghai in March 2004. DIAB is a joint venture between DI International Business Development (DIBD) and Asia Base A/S. Client Companies are members of the Confederation of Danish Industry (DI. Also, DIAB's Services are primarily offered to small- and medium sized companies.
工商信息
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统一社会信用代码
91310000763991770D