Quality Assurance Manager

Key Responsibilities:

1. Quality Assurance Leadership:

Develop, implement, and oversee quality assurance policies and procedures to ensure compliance with pharmaceutical regulations, industry standards, and internal quality standards.

Lead and mentor the QA team, providing guidance and support to ensure effective quality management practices.

Monitor key quality metrics and implement corrective and preventive actions to address any issues and drive continuous improvement.

2. SAP Implementation and Optimization:

Manage the implementation, configuration, and optimization of SAP Quality Management (QM) modules to support quality assurance processes.

Collaborate with IT and SAP consultants to ensure that SAP solutions are aligned with quality management needs and regulatory requirements.

Provide training and ongoing support to QA and production teams on SAP QM functionalities and best practices.

3. Audit Management:

Prepare for, conduct, and oversee internal and external audits, including regulatory inspections and certifications.

Address and resolve audit findings and non-conformities, implementing corrective actions as needed.

Maintain up-to-date knowledge of audit requirements and industry standards to ensure compliance.

4. Regulatory Compliance:

Ensure all QA processes are compliant with Good Manufacturing Practices (GMP), FDA, EMA, and other relevant pharmaceutical regulations.

Stay current with changes in regulatory requirements and ensure that QA processes are updated accordingly.

Coordinate with regulatory bodies and ensure timely and accurate submission of required documentation.

5. Continuous Improvement:

Identify and lead initiatives to improve QA processes, enhance efficiency, and ensure the highest quality standards.

Implement and promote best practices and continuous improvement methodologies within the QA department.

Analyze quality data and trends to drive decision-making and process enhancements.

6. Documentation and Reporting:

Oversee the creation, maintenance, and review of quality documentation, including Standard Operating Procedures (SOPs), validation protocols, and quality reports.

Ensure accurate and timely reporting of quality metrics and performance to senior management.

7. Supplier and Vendor Management:

Evaluate and monitor the quality of materials and components from suppliers to ensure compliance with specifications and standards.

Collaborate with suppliers to address quality issues and drive improvements in the supply chain.