Quality Assurance Executive

As a key member of our Quality Assurance team, you will be instrumental in upholding the highest standards of quality across our API and Intermediates production. Your responsibilities will span from corporate QA functions and validation processes to conducting internal audits, managing the Quality Management System (QMS), and ensuring thorough vendor qualification. You will play a critical role in maintaining compliance with regulatory requirements and driving continuous improvement initiatives within the organization.

Roles & Responsibilities :

Corporate Quality Assurance Management

1. Oversee and manage corporate QA functions, ensuring alignment with company policies and regulatory requirements.

2. Develop, implement, and maintain the Quality Management System (QMS) to ensure compliance and continuous improvement.

3. Lead the development and maintenance of Standard Operating Procedures (SOPs) to ensure consistent and compliant operations.

4. Manage and maintain the document control system to ensure accurate and up-to-date documentation.

5. Provide guidance and support to other departments on quality-related matters.

6. Ensure compliance with all applicable regulations and guidelines.

Validation and Qualification Activities

1. Ensure that all validation activities are performed in accordance with regulatory requirements.

2. Analyze validation data and prepare reports summarizing validation results.

3. Oversee the implementation of validation plans and ensure adherence to established protocols.

4. Review and approve validation documentation to ensure accuracy and completeness.

5. Develop and execute validation protocols for process validation, equipment qualification, and computer system validation (CSV).

6. Manage the validation process for equipment, processes, and computer systems to ensure compliance and reliability.

Auditing and Compliance

1. Ensure that all audit activities are performed in accordance with regulatory requirements.

2. Monitor and analyze quality metrics to identify trends and areas for improvement.

3. Lead the development and implementation of corrective and preventive actions (CAPA) to address audit findings and prevent recurrence.

4. Prepare audit reports and track corrective actions to ensure timely resolution of audit findings.

5. Manage external audits by regulatory agencies and customers.

6. Conduct internal audits to assess compliance with company policies, procedures, and regulatory requirements.

Vendor Qualification and Management

1. Maintain a list of approved vendors and ensure that all vendors are qualified in accordance with company procedures.

2. Collaborate with vendors to resolve quality issues and implement corrective actions.

3. Monitor vendor performance and track quality issues.

4. Review and approve vendor documentation, including quality agreements and certificates of analysis.

5. Conduct vendor audits to assess compliance with quality requirements.

6. Manage the vendor qualification process to ensure that suppliers meet company quality standards.

Deviation and Change Control Management

1. Ensure that all change control activities are performed in accordance with company procedures and regulatory requirements.

2. Review and approve change control documentation.

3. Assess the impact of changes on product quality and compliance.

4. Manage the change control process to ensure that changes are properly evaluated and implemented.

5. Review and approve deviation reports and track corrective actions to ensure timely resolution.

6. Manage the deviation management process to ensure that deviations are properly investigated and resolved.

Risk Management and Quality Improvement

1. Promote a culture of quality throughout the organization.

2. Monitor the effectiveness of quality improvement initiatives and track progress towards goals.

3. Lead quality improvement initiatives to enhance product quality and process efficiency.

4. Analyze quality data to identify trends and areas for improvement.

5. Implement and maintain a risk management program to proactively address quality risks.

6. Conduct risk assessments to identify potential quality risks and develop mitigation strategies.