Be part of something bigger at BD. Here, you’ll help us continually improve how we do things every day; to be more efficient, more effective and better serve our customers. You’ll do this within an exceptional team all striving to make sure that everything we do complies with regulations and standards, not just because it’s the right thing to do, but because our products impact people’s quality of life. Here, you’ll put your compliance experience, high expectations and attention to detail to the very best use: advancing the world of health™. At BD, you can make a true difference of one.
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Job Type:
Full-Time -
Job Level:
Entry to Senior -
Travel:
Varies -
Salary:
Competitive -
Responsibilities
Job Description Summary
Quality assuranceMaintain the quality system of the Yixing factory and its adequacy and effectiveness. Organize on-site GMP, ISO standards and regulatory compliance training. Responsible for coordinating customer complaint investigations at production sites. Responsible for the coordination of CAPA. All activities are carried out in accordance with the relevant GMP and quality system standards, especially ISO14385. Ensure that effective file systems are in place and maintained to meet our quality system requirements. Ensure that the facility is able to meet the requirements of external audits. Responsible for supplier audits.
Job Description
Regulatory compliance
1.Manage internal quality audit procedures, including:
Establish and maintain internal audit guidelines. Prepare and maintain an internal quality audit program. Internal quality audits are monitored and tracked against the approved internal quality audit plan. Manage designated internal quality auditors. Conduct internal quality audits in accordance with the prescribed procedures. Submit status updates and trend analysis reports to the management team on a regular basis.
2.Maintain external quality audit procedures, including:
Establish and maintain an external audit program. Responsible for preparing external quality audits conducted by regulatory authorities or other third parties. Follow-up on corrective actions taken for non-conformities found in audits to ensure that corrective actions are implemented as planned. Perform trail audits to verify corrective actions implemented. Provide regular status updates and trend analysis reports to department managers and oversight teams.
Required Skills
Optional Skills
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Primary Work Location
CHN Yixing PlantAdditional Locations
Work Shift
Success Profile
What makes a successful Quality Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Ambitious
- Collaborative
- Goal-oriented
- Persuasive
- Results-driven
- Self-starter