上海市-浦东新区 | 若干人
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.