Quality Assurance Manager – Pharma Distribution

Job Title: Quality Assurance Manager – Pharma Distribution

Location: Saki Naka, Mumbai

Salary: ₹60,000 – ₹70,000 per month

Employment Type: Full-Time

Industry: Pharmaceutical, Distribution, Logistics

Experience: Minimum 5 Years Preferred

Job Purpose

Key Responsibilities

• Develop, implement, and maintain the Quality Management System (QMS) in accordance with current Good 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.
  

Required Skills & Qualifications

• Bachelor's degree in Pharmacy, Science, or related field
• Strong knowledge of GDP, cGMP, QMS, FDA, DEA and local regulations
• Minimum 5 years in quality assurance in a pharma or distribution environment
• Experience in audits, CAPA, SOP management, and regulatory inspections
• Strong documentation, analytical, and compliance skills
  

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