Quality Manager

1 day ago

mumbai, India Neuraleap Technologies Group Full time

Job Title: Quality Assurance ManagerLocation: Mumbai- SakinakaDepartment: Quality AssuranceReports To: FounderEmployment Type: Full-timeJob purpose – The Quality Assurance Manager is responsible for overseeing the quality systems andregulatory compliance programs within a pharmaceutical distribution environment. This role ensuresthat 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) inaccordance with current Good Distribution Practices (GDP) and applicable regulatoryrequirements.● Ensure compliance with all federal, state, and local regulatory requirements, includingFDA.● Lead and manage internal and external audits, regulatory inspections, and customeraudits.● 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 forwarehouse and distribution staff.● Manage product complaints, returns, recalls, and investigations.● Collaborate with warehouse and operations teams to ensure adherence to producthandling, storage, and transportation standards.● Monitor quality metrics and generate reports for senior management.● Review and approve batch documentation, temperature excursion reports, andrelease authorizations.● Maintain current knowledge of industry regulations and standards and providestrategic 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, orhealthcare 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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