A company in the medical device industry is seeking to fill the above-mentioned position.

Purpose of this job:
In general:
To ensure that NNTP are in compliance with pertinent laws, regulations and requirements defined for the site in relation to manufacture, control and release of Pharmaceutical products and medical devices.

Has the authority to order a production stop and stop of delivery at the site.
In case of production stop or stop of delivery, report to the head of SVP area quality immediately.

To ensure implementation of top level procedures and Novo Nordisk A/S quality policy and quality strategy in NNTP.

To ensure that the quality management system in NNTP is maintained, updated and continuously improved.

Specifically:
Responsible for managing NNTP Quality including the following functions in NNTP: QA Diabetes Products, QA NovoPen, QC Diabetes products, QC NovoPen, QC PPM, Metrology and Quality System, Document Control.

Area of responsibilities:
Main Tasks:

- Appointed management representative for NNTP.
- Member of the Management team in NNTP.
- Responsible for ensuring the Quality management system in NNTP effectively established and maintained.
- Responsible for reporting on the performance of the annual KPI and quality management system to the head of NNTP and head of D&S Quality.
- Responsible for ensuring that pertinent laws, regulations and requirements defined for NNTP are followed. This includes the EEC directive, ISO 13485, ISO 9001 and Chinese GMP and China regulations for manufacturing of medicine and medical device.
- Responsible for ensuring that Novo Nordisk Quality Policy and Novo Nordisk top level procedures are followed in NNTP;
- Responsible for QC-test and release of products in NNTP;
- Liaison with external parties on matters relating to the quality system;
- Responsible for ensuring education, training, motivation of the employees and an optimal utilization of the resources in the area.
 
Supervision:
- Employees of NNTP Quality department
 
Main customers:
- Internal: NNTP Quality employees, NNTP management, all other departments of NNTP and NNCP, DMS, D&S.
- External: the local authority, local suppliers

Education and Experience Requirements of the Position:
• Bachelor degree in pharmaceutical/engineer;
• Quality management experiences in pharmaceutical industry; be familiar with Chinese GMP, ISO 9000 standard, ISO13485 and other relevant regulations;
• >5 years management experience;
• Experience in training and skilled in communication;
• Good English communication skill

Interested candidates please email cover letter and cv to singcham@singcham.com.cn

We regret only shortlisted candidates will be notified.

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