Quality Assurance Manager-(Pharma Sector)

Job Title: Quality Assurance Manager
Location: Mumbai- Sakinaka Department: Quality Assurance Reports To: Founder Employment Type: Full-time Job purpose - The Quality Assurance Manager is responsible for overseeing the quality systems andregulatory compliance programs within a pharmaceutical distribution environment. 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 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. 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.