Lab Quality Assurance III - Shanghai
About this role
Support Statement
Support departmental operation to assure quality and compliance to the regulatory requirements. Provides GLP/GCP/CAP audit and inspection support to the Quality Assurance Section and reports to upper management.
Major Responsibilities
- Monitor updates for regulatory legislations and/or guidelines.
- Conduct review of documents, procedures, facilities, etc., to ensure compliance to the regulatory requirements.
- Perform review and quality assurance for reports and documents to be submitted to the regulatory departments.
- Review the responses of the audit or inspection findings for appropriateness and completeness.
- By following approved procedure and schedules, conducting audits either independently or collaboratively with other QA auditors.
- Ensure timely completion of routine QA procedures.
- Work collaboratively with each department head in the assessment of vendors' qualifications.
- Assisting in project related or non-project related audits/inspections conducted by customer or regulatory authorities.
- Write and issue audit reports or any non-conformances form in accordance with SOPs.
- Ensure that audit findings are clearly made to the relevant project team members, department heads and upper management.
- Participate in the investigation of non-compliance, problem reporting, or complaint issues. Follow through to verify corrective/preventive actions are appropriate and enforced as well as tracking and monitoring performances of the actions taken before case closed.
- Perform housekeeping on documents generated as a result of QA activities.
- Provide inputs to the development of departmental quality system process.
- Manage SOPs according to company policy or regulatory agencies.
- Conduct provisional tasks assigned by upper management.
Qualifications & Experience
Education
- Bachelor's degree in a scientific discipline. Advanced degree is a plus.
Knowledge, Skills, and Abilities
- Good knowledge of regulatory requirements.
- Good communication skills.
- English reading and writing skills.
- Computer skills.
- Detail orientated.
Experiences
Lab Quality Assurance II
- 3 or more-year experience in GLP, GCP, or CAP industry is a plus.
- 2 years of CRA is a plus.
Lab Quality Assurance III
- 5 or more-year experience in GLP, GCP, or CAP industry is preferred.
- 3 years of CRA is a plus.
Novotech is a global full-service clinical Contract Research Organization (CRO).
At Novotech, ambition meets opportunity. As a globally recognized leader in clinical research and scientific advisory services, we are proud to combine our position at the forefront of the industry with an award-winning workplace culture that values ambition, innovation, and growth. Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE), we are committed to fostering an environment that reflects the life-changing work we do.
Since 1997, we have expanded our global footprint, now with 30+ offices across Asia-Pacific, the United States, and Europe. This growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide.ย
At Novotech, our employees are at the heart of our success. By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients.
With access to mentorship opportunities, professional development programs, and a dynamic community, Novotech offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare. Join us to be a part of a team that values your contributions and supports your ambition to make a global impact.
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