Job Description
Job Summary
- Quality Assurance (QA) Manager will beresponsible for ensuring that products and processes meet quality standards and regulatory requirements.
- They oversee the development and implementation of quality management systems, monitor testing, and lead the QA team.Key responsibilities include reviewing documentation, handling deviations, managing audits, and providing training.
Key Responsibilities
- Quality Management System (QMS) Development and Implementation: Establishing and maintaining the company's QMS to ensure compliance with regulatory standards (e.g., GMP, GDP).
- Compliance: Staying up-to-date on regulatory changes and ensuring that all processes and products meet current regulations.
- Team Leadership: Managing the QA team, providing guidance and support, and ensuring that team members are competent and motivated.
- Documentation Review and Approval: Reviewing and approving documentation related to manufacturing, testing, and release of products.
- Deviation Management: Investigating and managing deviations from standard operating procedures (SOPs).
- Audit Management: Preparing for and leading regulatory inspections and customer audits.
- Quality Metrics and Reporting:Implementing and monitoring quality metrics, and reporting findings to management.
- Continuous Improvement: Identifying areas for improvement in quality systems and processes.
- Training and Development:Providing training to staff on quality procedures and regulations.
- Supplier Quality: Working with suppliers to ensure the quality of raw materials and components.
- Product Release: Approving the release of products for distribution.
- Collaborative Work: Working with cross-functional teams to address quality issues and ensure timely resolution.
- Risk Management: Identifying and mitigating potential risks to product quality.
Qualifications and Skills
- Candidate should possess a Bachelor's Degree with 5 - 6 years work experience.
- Knowledge: In-depth knowledge of GMP, GDP, GLP, and other relevant regulations.
- Skills: Strong leadership, communication, and interpersonal skills;excellent analytical and problem-solving skills.