Officer /Executive - QA & FDA Licensing

Purpleeon Consulting Services; Pune District; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Purpleeon Consulting Services in Pune is seeking a Regulatory Affairs and Quality Assurance professional to manage licenses, registrations, and documentation while ensuring compliance with FDA, FSSAI, and other regulatory requirements.

You will coordinate with Production, QA, and Engineering to support audits, validate processes, review packaging artworks, and maintain SOPs and change controls as part of the continuous quality program. This is an on-site role in a growing manufacturing setup.

Responsibilities

• Prepare, submit, and track licenses, registrations, and related documents.
• Maintain SOPs and QMS documents, and support QMS implementation.
• Manage validation protocols, reports, and product stability documentation.
• Review packaging artwork and labeling for regulatory compliance.
• Coordinate with Production, Stores, Engineering, and other teams.
• Support audits, inspections, and regulatory reviews.

Job description

Job Summary :

To support regulatory compliance, licensing activities, Quality Management Systems (QMS), and documentation control while ensuring compliance with applicable FDA, FSSAI, and other regulatory requirements.

Key Responsibilities :

1. Regulatory Affairs and Licensing

Prepare, submit, and track applications for Manufacturing Licenses, Test Licenses, Ayurvedic Product Licenses, and FSSAI registrations/licenses.

Coordinate regulatory submissions and approvals through CDSCO, NSWS, and other applicable regulatory portals.

Ensure compliance with applicable regulatory requirements and maintain related records.

2. Documentation and QMS Management

Prepare, review, issue, and maintain SOPs and other quality system documents.

Support implementation and maintenance of the Quality Management System (QMS).

Monitor and maintain Change Controls, Deviations, and related quality records.

Prepare and compile Annual Product Quality Review (APQR) reports.

3. Validation and Quality Documentation

Prepare and maintain Process Validation Protocols, Validation Reports, and Stability Protocols.

Review Batch Manufacturing Records (BMR) and Batch Packing Records (BPR) for compliance and completeness.

Maintain validation and regulatory documentation in accordance with GMP requirements.

4. Artwork Review and Compliance

Review and approve packaging artworks and label content in accordance with regulatory and statutory requirements.

5. Cross-Functional Coordination

Coordinate with and Production, Stores, Engineering, and other departments for regulatory, validation, and quality assurance activities.

Provide support during audits, inspections, and regulatory compliance activities.

6. Additional Responsibilities

Perform any other quality assurance and regulatory compliance activities assigned by management from time to time.