Send Resume to HR Mail at Bal Pharma Recruiting For API- Quality Assurance Sr. Executive

QMS Implementation & Maintenance:

1. Develop, implement, and maintain the Quality Management System (QMS) to ensure compliance with regulatory standards (e.g., ICH, WHO, FDA).

2. Oversee document control systems, including SOPs (Standard Operating Procedures), CAPAs (Corrective and Preventive Actions), and change control processes.

Regulatory Compliance:

1. Ensure the companys API production processes meet global regulatory standards (e.g., GMP, ICH Q7 guidelines).

2. Prepare for and participate in audits and inspections from regulatory authorities (e.g., FDA, EMA).

3. Manage internal audits to monitor compliance and effectiveness of QMS.

Quality Control & Assurance:

1. Monitor and ensure the quality of raw materials, intermediates, and final APIs.

2. Collaborate with the production team to identify and mitigate risks in the manufacturing process.

3. Conduct root cause analysis for deviations, and implement CAPAs.

Training & Awareness:

1. Conduct training sessions for staff on QMS principles, regulatory requirements, and best practices in quality assurance.

2. Promote a culture of continuous improvement and quality consciousness across the organization.

Risk Management:

1. Apply risk management principles to anticipate and prevent potential quality issues.

2. Ensure proper handling of product complaints and non-conformances.

Batch Record Review:

1. Review batch manufacturing records to ensure compliance with GMP and QMS requirements.

2. Approve or reject batches based on compliance to quality standards.

Supplier Qualification:

1. Conduct audits and assessments of suppliers to ensure raw materials and intermediates meet required quality standards.

2. Maintain and monitor supplier quality agreements.

Documentation & Reporting:

1. Maintain accurate and detailed records of all QA activities.

2. Generate reports for management, outlining quality issues, audit results, and performance metrics.

Key Skills & Knowledge

• Deep understanding of QMS principles and pharmaceutical regulations (ICH Q7, GMP, FDA).
• Experience in risk management and root cause analysis.
• Familiarity with documentation standards and electronic QMS tools.
• Strong communication and leadership skills for managing cross-functional teams.

Please share your CV at placement@balpharma.com