Daniel Ren Email & Phone Number

Suzhou, Jiangsu, China

• Generate innovative solutions to complex technical problems through the use of multiple disciplines and technical principles.
• Assume the Study Director’s role and act as the single point of study control managing stability studies to support new product development, geography expansion and sustaining product life cycle management.
• Develop and review stability strategy, study design and protocol; perform trend review on stability data; prepare and review stability report and expiration dating package.
• Drive OOS/OOT investigations, and ensure sound technical evaluations that characterize the stability trending of suspect data.
• Author stability sections of regulatory submissions and ensure that submissions are technically sound and comply with regulatory and industry standards.
• Act as stability Subject Matter Expert (SME) to provide expertise and assessment to defend change controls for assigned product family.

Hangzhou, Zhejiang, China

• 
• Organize daily analytical work of Lab to ensure its accuracy and timeliness
• Support to process validation、cleaning validation and utility system validation
• Handle deviation and OOS case in QC, establish CAPA
• Complete quality system in QC、follow the standards and regulation of GMP/GLP, maintain and update the whole system
• Ensure all activities of QC run under compliance

Suzhou, Jiangsu, China

• 
• Routine management：Responsible for routine running management of Lab.
• Quality control management Responsible for chemical and microbiological test work arrangement include utility system、raw materials、semi-product、packaging materials、finished product、stability samples、retentions and etc.
• Responsible for bioburden、bacterial endotoxin、sterility test method validation and application.
• Validation management：Responsible for implementing validation work about all kinds of analysis method within Lab, supply the chemical and microbiological test support on the other validation work such as.
• Environmental control management：Responsible for the arrangement about regular environment monitoring for all clean area, ensure the qualified environment meet manufacturing requirement, focus on continuous improvement.

Tianjin City, China

• 
• Perform validation tests for water for injection system according to monitoring requirements.
• Perform tests and release for kinds of raw materials and packaging materials.
• Perform tests for kinds of products including new product 、finished product 、retention samples and stability study samples.
• Draft and review the procedure of test for packaging materials and new product.
• Assist in validating of process and new manufacture line and supply the analytical service.

Shenyang, Liaoning, China

• 
• Perform tests and release for kinds of finished product、half- finished product 、 raw materials and packaging materials etc.
• Prepare the chemical reagent、volumetric solution and etc.for test work.
• Master the ability of chemical analysis skills and direct the operation of new staff.
• Complete the stability study of emphases retention and report.
• Perform the methodology study and test for new product.