Quality Manager

1 day ago

Mumbai, Maharashtra, India Neuraleap Technologies Group Full time ₹ 12,00,000 - ₹ 36,00,000 per year

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 and
regulatory 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.

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