Main Objective:
*The Quality Manager’s key role is to ensure Besins Healthcare products are received and distributed in China according to GSP requirements and in compliance with NMPA standards;
*This function ensures quality compliance with GxP and Besins Healthcare Standard Operating Procedures (SOP) and that quality product is available to patients;
*Detailed-oriented and a strong understanding of QA methodologies.
Job interactions & interface:
*Internally this position interacts with all departments in Besins Healthcare, in particular with Supply Chain, Market Access, Medical Reps, Regulatory and Besins Healthcare Corporate Quality.
*Externally this position interacts with Besins Healthcare Distributors in China (third party logistics-distributors and wholesalers), Hospitals and Health Care Professionals in addition to NMPA if necessary (Inspectorate).
Principal Accountabilities:
Quality Assurance - responsible for the following activities:
*Set up QMS in Besins China;
*Coordination for shipments of goods to China (data-loggers & other specific precautions for shipment of goods);
*Handling of product complaints in coordination with BH Corporate Quality and feedback global QA team;
*Establishment, periodic review, revision and implementation of SOP’s for BH Shanghai;
*Conducting inspections of distributors & wholesalers as required by GxP requirements;
*Acting as primary quality contact person with Third Party Logistics providers;
*Implementing recall procedures if necessary, in collaboration with BH Corporate Quality and local distributors;
*Training of distributors, wholesalers, Hospitals and Health Care Professionals related to handling and storage of BH products;
*Periodic training of relevant staff.
Miscellaneous:
*Strive to uphold Besins Healthcare’s values;
*Other ad-hoc support
Skills & Qualifications:
*Bachelor's degree or above;
* Proven experience in QA within pharmaceutical industry; in which at least 1-2 years’ experience in medicine distribution companies, either principals or distributors;
*Strong sense of responsibility, management ability, judgment ability, communication ability, writing ability, influence ability, planning and execution ability;
*Solid decision-making skills, detail-oriented person;
*Excellent communications skills – verbal, written & listening (both in Mandarin & English);
*Solid computer skills using MS Office, and MS Outlook.