Quality Manager

1 week ago

Mumbai Metropolitan Region, India Neuraleap Group Full time ₹ 20,00,000 - ₹ 25,00,000 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.

Skills: fda, dea, cgmp, gdp,quality assurance,regulatory requirements,compliance

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