Quality Assurance Manager

Drlogy; Surat; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Drlogy is seeking a Quality Assurance Manager to lead and manage quality assurance activities across manufacturing and operations. The ideal candidate will ensure compliance with cGMP, GLP, and regulatory guidelines, develop and implement SOPs and quality systems, and oversee validation activities. Strong leadership and experience in pharmaceuticals are essential for maintaining the quality culture and regulatory compliance across the organization.

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.
• Conduct internal audits and ensure readiness for external regulatory audits.
• Coordinate with regulatory authorities and manage compliance requirements.
• Oversee validation activities including process validation.
• Ensure data integrity and compliance with documentation standards.
• Provide training and guidance to staff on quality systems.
• Work closely with QC, production, and R&D teams.
• Review and approve change control documents.
• Monitor quality metrics and drive continuous improvement initiatives.
• Ensure proper handling of complaints and investigations.
• Maintain quality risk management systems.
• Ensure adherence to safety, health, and environmental guidelines.
• Maintain proper documentation for audits.
• Evaluate vendor quality and approve suppliers.
• Support product development and technology transfer activities.

Job description

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.