What are the responsibilities and job description for the Corporate Quality and Regulatory Affairs Specialist - China position at TalentBurst, Inc.?
Corporate Quality and Regulatory Affairs Specialist - China
06 Months
Los Angeles, CA
Summary :
Responsible for coordinating the activities in the areas of Regulatory and Quality of Client Biopharma business to ensure Chinese regulations are met.
The principal functional responsibilities include handling and coordinating the investigation of Customer Complaints from China, assisting product and process submissions to Chinese Regulatory Authorities, managing quality or RA projects that involves multiple departments / companies, and supporting cGMP inspections of Clients' facilities and operations by Chinese Authorities / distributors / customers.
Primary responsibilities for role :
- Participate communications related to Quality and Regulatory Affairs between the Bioscience industrial group and Clients China, manage communications with Clients distributor and support communications with Chinese Health authorities conducted by the Technical Direction of Client China and his / her team.
- Provides direct and clear communication to management regarding the current status of quality and regulatory for China.
- Participates in regulatory inspections / audits from China as facilitator, translator during the inspection or in the written responses, if applicable.
- Communicates with cross functional departments and support groups to improve departmental performance and efficiency Host meetings and generate meeting minutes
Requirements :
Bachelor's degree in life science, pharmacy, pharmaceutical science or related fields.
TB_PH
