The Quality Assurance professional will lead and oversee quality assurance activities to ensure compliance with cGMP, GMP, FDA regulations, and GLP standards. 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. This role is responsible for supervising quality control teams, managing audits, and driving continuous improvement initiatives to maintain the highest standards of product quality and regulatory compliance.
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.
