Job purpose– The Quality Assurance Manager is responsible for overseeing the quality systems and regulatory compliance programs within a pharmaceutical distribution setting. This role ensures that all products handled and distributed meet applicable regulatory requirements (e.g., FDA, DEA, cGMP, GDP), company standards, and customer expectations.

Key Responsibilities:

● Develop, implement, and maintain the Quality Management System (QMS) in accordance with current Positive Distribution Practices (GDP) and applicable regulatory requirements.

● Ensure compliance with all federal, state, and local regulatory requirements, including FDA.

● Lead and manage internal and external audits, regulatory inspections, and customer audits.

● Conduct risk assessments and implement corrective and preventive actions (CAPAs) to address non-conformances and audit findings.

● Oversee the documentation control system, including SOPs, change controls, deviations, and quality records.

● Develop and deliver training programs on quality and compliance topics for warehouse and distribution staff.

● Manage product complaints, returns, recalls, and investigations.





● Collaborate with warehouse and operations teams to ensure adherence to product handling, storage, and transportation standards.

● Monitor quality metrics and generate reports for senior management.

● Review and approve batch documentation, temperature excursion reports, and release authorizations.

● Maintain current knowledge of industry regulations and standards and provide strategic input on quality improvement initiatives.

Qualifications:

Education:

● Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related field required.

Experience:

● 8+ years of experience in quality assurance within pharmaceutical, biotech, or healthcare distribution.

● Knowledge of FDA regulations, GDP, cGMP, and other applicable quality standards.

● Experience with regulatory inspections and compliance audits.

● Experience with controlled substances handling is a plus.

Working Conditions:

● Primarily office-based with monthly/quarterly visits to branches.

● May require occasional travel for audits, inspections, or training.

Pay: ₹1,700,000.00 - ₹2,000,000.00 per year

Work Location: In person

📌 Quality Assurance Manager Pharma (Andheri)
🏢 Silgate solutions
📍 Andheri