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For Employers

Quality Manager

Neuraleap Group

8 years

5 - 6 Lacs

mumbai metropolitan region

Posted:6 hours ago| Platform:

Apply

Skills Required

compliance management audits risk audit documentation training storage transportation metrics reports regulations healthcare

Work Mode

On-site

Job Type

Full Time

Job Description

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

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Quality Manager