Quality Assurance Manager
2 weeks ago
BioTech Healthcare is a leading medical device company dedicated to improving patient outcomes through innovative products and services. We are committed to delivering high-quality products that meet the needs of our customers while ensuring compliance with regulatory requirements.
Salary
We offer a competitive salary package to attract and retain top talent in the industry. Our compensation structure is designed to recognize individual contributions and provide opportunities for career growth and development.
Job Description
The Assistant General Manager QA will play a critical role in ensuring the quality and compliance of our products. The successful candidate will have a strong background in quality assurance, regulatory compliance, and project management. Key responsibilities include:
Designing, implementing, and maintaining a robust Quality Management System (QMS) framework in line with regulatory requirements and industry standards
Authorizing and reviewing SOPs, master documents, and quality protocols to ensure comprehensive compliance across all operational processes
Overseeing the approval process for Site Master Files, Validation Master Plans, Quality Manuals, and stability summary reports
Ensuring procedural compliance in handling Change Control Notices (CCN), deviations, market complaints, Out-of-Specification (OOS) issues, CAPA, and IPQA non-conformances
Conducting document reviews for new product launches to ensure alignment with regulatory requirements
Leading internal audits and self-inspections to assess compliance with quality standards and identify areas for improvement
Investigating quality-related issues, conducting root cause analysis, and implementing corrective and preventive actions (CAPA)
Driving quality improvement projects and initiatives to enhance operational efficiency and compliance
Required Skills and Qualifications
To be successful in this role, you will need to possess the following skills and qualifications:
Strong expertise in Quality Assurance, QMS implementation, and regulatory compliance
Proficiency in managing quality projects, conducting internal audits, and performing gap analyses
In-depth understanding of GMP, GDP, ISO 13485, and FDA regulations
Ability to lead and manage cross-functional teams effectively
Competence in conducting training programs and implementing quality improvement initiatives
Benefits
We offer a range of benefits to support your physical, emotional, and financial well-being, including:
A comprehensive health insurance plan
A retirement savings plan with employer matching
A generous paid time off policy
Access to professional development opportunities and continuing education resources
Others
As a member of our team, you will have the opportunity to work on exciting projects, collaborate with talented professionals, and make a meaningful contribution to the healthcare industry.
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