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.• Develop, implement or consolidate robust process/procedures to maintain compliance while improving efficiency and effectiveness. • Demonstrate leadership and technical expertise in resolving technical problems and delivering business and project results.• Drive Change Control Management (CCM), Nonconformance (NCR), Corrective And Preventive Actions (CAPA) to ensure the compliant environment for work development.• Provide training and coach to junior staff as assigned.

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 • Drive the continuous improvement project in QC • Establish self-inspection system、participate internal and external GMP audit, complete CAPA according to audit findings • Establish optimal operation pattern in QC and build high efficient team • QC EHS management • Analytical method maintenance、validation and development • Staff training and performance assessment • Equipment maintenance、calibration and validation • Materials test and release on time • Stock security assurance of consumables and purchase • Initiate reasonable budget of QC and maintain it • Cooperate with other department and finish cross-functional issues.

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 process、sterilization process、equipment、environment and etc. • 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 of cleaning area. • Stability study management：Responsible for evaluating the quality stability of raw materials、semi-product and finished product, provide data for the evaluation about the storage of raw materials, the expiration date of the product, process parameters change and optimization, and etc. • Equipments management：Responsible for the management of analytical instrument, equipment, reagent, test solutions, standard substances, reference standards, standard solutions, culture and medium. Purchase matched analytical instrument by requirements. Responsible for the validation and regular maintenance for all test equipments. • Staff training and management：Responsible for the training of all staff in the lab not only concerned with specific tasks, but with regulations as well. Perform KPI and target setting regularly, keep communicating and summarizing regularly, focus on continuous improvement about staff management.

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. • Analysis method study for new product. • Perform relevant activities for equipment including daily use、maintenance、validation and calibration. • Draft and revise the standard operating and calibration procedure. • Establish the instrument document, update the data and information on time for all the instrument documents which are required to be calibrated according to calibration program periodically. • The instruments I have used include HPLC、UV、IR、AAS、Particle Counting and etc. • Draft 、revise and review the kinds of files and SOPs of lab. • Update the specifications, test methods and documents on time and make them be in accordance with current quality systems requirement. • Manage and purchase testing materials (such as reagents 、consumptive sets、standard sample、 chromatogram column、 waste materials and etc.). • Perform corrective and preventive actions in order to be suitable for product quality management & compliant with the current GMP requirements。 • Perform any other work delivered by Supervisor and Quality Manager. • Participate in the audit of Lab’s section about ISO 14000、18000、9000 system of our company given by professional company. • Take part into the periodic self-check work of company . • Take appropriate EHS trained and report the incidents of noncompliance with EHS policy on time.

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. • Draft the test procedure for new product. • Master practical operational experience of great、more advanced and analytic instrument such as GC、HPLC、TLC、AAS、UV、IR、Turns on Lathe Optical Instruments、Quality and Technology In Particle Counting、Mettler DL70ES Titrator and etc. • Maintain and calibrate all analytic instruments needed. • Perform the performance qualification of accurate instrument such as GC、HPLC、TLC、AAS、UV and etc. according to the requirement. • Draft and revise the SOP of analytic instruments. • Complete and manage kinds of documents of lab complying with requirement of quality management system. • Take part into the GMP audit about lab section given by SFDA.