Quality Assurance Manager
3 days ago
**Job Title:** Quality Assurance Manager
**Company:** Company
**Job Summary:
We are seeking a highly skilled Quality Assurance Manager to lead our quality assurance activities and ensure compliance with regulatory requirements. The ideal candidate will have a strong background in quality management systems and a proven track record of ensuring high-quality products and processes within a regulated industry.
Key Responsibilities:
- Team Leadership and Supervision:
- Supervise and mentor a team of quality assurance professionals, including quality control inspectors and analysts.
- Schedule and allocate resources effectively to meet production and testing requirements.
- Provide training and development opportunities to enhance team skills and knowledge.
- Regulatory Compliance:
- Ensure that all activities comply with cGMP, GMP, FDA regulations, and GLP standards.
- Monitor and review processes and documentation to ensure adherence to regulatory requirements.
- Prepare and manage inspection readiness, including internal and external audits.
- Quality Assurance and Control:
- Oversee the implementation and maintenance of quality assurance programs, including inspection, testing, and validation processes.
- Investigate and resolve quality issues, non-conformances, and customer complaints.
- Conduct root cause analysis and implement corrective and preventive actions (CAPAs) as necessary.
- Documentation and Reporting:
- Maintain and review quality documentation, including standard operating procedures (SOPs), validation protocols, and batch records.
- Prepare and present quality reports, including key performance indicators (KPIs) and trend analyses, to senior management.
- Continuous Improvement:
- Drive continuous improvement initiatives to enhance product quality and operational efficiency.
- Implement and manage quality improvement projects and ensure effective change management.
- Cross-Functional Collaboration:
- Collaborate with other departments, such as Production, R&D, and Supply Chain, to support quality objectives and resolve quality-related issues.
- Participate in cross-functional teams to support product development, process optimization, and regulatory submissions.
Qualifications:
- Bachelor's degree in a relevant field (e.g., Chemistry, Biology, Engineering) or equivalent experience.
- Proven experience in a quality assurance role within a regulated industry, preferably with supervisory experience.
- In-depth knowledge of cGMP, GMP, FDA regulations, and GLP standards.
- Strong understanding of quality management systems, quality control methodologies, and regulatory compliance requirements.
- Excellent problem-solving skills and the ability to lead investigations and implement effective CAPAs.
- Effective communication and interpersonal skills, with the ability to work collaboratively across teams.
- Proficiency in using quality management software and tools.
- Detail-oriented with strong organizational and multitasking abilities.
Preferred Qualifications:
- Certification in quality management (e.g., ASQ Certified Quality Engineer or Certified Quality Auditor) is a plus.
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