DB-Quality Assurance Auditor/...
2 weeks ago
Primary Responsibilities and Accountabilities:
- Independently perform Quality activities including preparation, conductance, presentation, and timely reporting of outcomes, and evaluation of actions executions.
- Independently perform laboratory internal audits, facility inspections and study audits, recognize nonconformities, present observations and associated compliance risks to the teams, prepare audit reports.
- Manage quality issues to ensure all actions are appropriately and timely addressed.
- Lead discussions with team members and report any nonconformities and issues to management in a timely manner.
- Review internal SOPs, review study plan, data, and report to identify issues.
- Perform csv audit, provide compliance consultation related to csv related activities.
- Identify and coordinate to resolve potential risk areas through working with the team and management
- Provide training to business stakeholders as required.
- Perform tasks as assigned by management.
- Participate in authority inspections, CAP accreditations as needed.
Qualifications:
- MS, BA degree in the quality related filed, or an equivalent education, training and experience.
- In-depth knowledge, maintain awareness and expertise in GLP/GCLP/GCP regulations and standards.
- 2 years’ experience in pharmaceutical industry with Quality Assurance background in a CAP/ISO15189/CNAS/GLP laboratory is preferred.
- Demonstrated knowledge in drug development and laboratory management.
- Good management, high discipline and proactive.
- Excellent communication skills and team work spirit.
- Confluent in reading, writing and speaking English.
-
Quality Intern
4 weeks ago
Pudong, China Corning Full timeRequisition Number: 62355 Corning is vital to progress – in the industries we help shape and in the world we share. We invent life-changing technologies using materials science. Our scientific and manufacturing expertise, boundless curiosity, and commitment to purposeful invention place us at the center of the way the world interacts,...
-
TDI - Testing Engineer - Associate
3 weeks ago
Pudong Xinqu, China 0912 Deutsche Bank (China) Co., Ltd., Shanghai Branch Full timeDescription : Details of the Division and Team Technology underpins Deutsche Bank’s entire business and is changing and shaping the way we engage, interact and transact with all our stakeholders, both internally and externally. Our Technology, Data and Innovation (TDI) strategy is focused on strengthening engineering expertise, introducing an...
-
TDI - IT Application Owner (ITAO) - AVP
1 week ago
Pudong Xinqu, China 0912 Deutsche Bank (China) Co., Ltd., Shanghai Branch Full timeDescription : Details of the Division and Team Technology underpins Deutsche Bank’s entire business and is changing and shaping the way we engage, interact and transact with all our stakeholders, both internally and externally. Our Technology, Data and Innovation (TDI) strategy is focused on strengthening engineering expertise, introducing an...
-
Pudong Xinqu, China 0912 Deutsche Bank (China) Co., Ltd., Shanghai Branch Full timeDescription : Details of the Division and Team Technology underpins Deutsche Bank’s entire business and is changing and shaping the way we engage, interact and transact with all our stakeholders, both internally and externally. Our Technology, Data and Innovation (TDI) strategy is focused on strengthening engineering expertise, introducing an...