Quality Assurance Manager

The Quality Assurance Manager will be responsible for developing, implementing, and maintaining quality systems in line with cGMP and regulatory requirements. This requires strong leadership, in-depth knowledge of pharmaceutical quality standards, and the ability to manage audits, documentation, and cross-functional coordination.

Roles and Responsibilities:

• Lead and manage all Quality Assurance activities across manufacturing and operations.
• Ensure compliance with cGMP, GLP, and regulatory guidelines.
• Develop, review, and implement SOPs, policies, and quality systems.
• Oversee batch record review and ensure proper documentation practices.
• Approve or reject raw materials, in-process materials, and finished products.
• Monitor deviations, OOS, OOT, and implement CAPA (Corrective and Preventive Actions).
• Conduct internal audits and ensure readiness for external regulatory audits.
• Coordinate with regulatory authorities and manage compliance requirements.
• Oversee validation activities including process validation, cleaning validation, and equipment qualification.
• Ensure data integrity and compliance with documentation standards.
• Provide training and guidance to staff on quality systems and compliance.
• Work closely with QC, production, and R&D teams to maintain quality standards.
• Review and approve change control documents and ensure proper implementation.
• Monitor quality metrics and drive continuous improvement initiatives.
• Ensure proper handling of complaints, recalls, and investigations.
• Maintain quality risk management systems and mitigation strategies.
• Ensure adherence to safety, health, and environmental guidelines.
• Maintain proper documentation for audits and inspections.
• Evaluate vendor quality and approve suppliers as per standards.
• Ensure compliance with global regulatory requirements if applicable.
• Implement best practices for quality assurance and process improvements.
• Manage and mentor QA team members and ensure team development.
• Ensure timely closure of audit observations and compliance gaps.
• Support product development and technology transfer activities.
• Maintain high standards of quality culture across the organization.
• Stay updated with regulatory changes and industry best practices.
• Contribute to overall product quality, compliance, and organizational success.