Quality Analyst (QA) - Assistant Manager

• Prepare, review, and maintain regulatory submissions and documentation in compliance with applicable regulatory guidelines.
• Coordinate preparation of dossiers, variations, renewals, amendments, and other regulatory submissions.
• Review product documentation, specifications, analytical data, stability data, and manufacturing information for regulatory compliance.
• Work closely with Quality Assurance, Quality Control, R\&D, Production, and other cross-functional teams for regulatory requirements.
• Ensure regulatory documents are accurate, complete, properly controlled, and submitted within defined timelines.
• Support responses to regulatory queries, deficiencies, observations, and requests for additional information.
• Maintain regulatory databases, submission trackers, licenses, certificates, approvals, and related records.
• Review and assess QA-related documents, deviations, CAPA, change controls, SOPs, and quality documentation for their regulatory impact.
• Monitor changes in regulatory guidelines and assess their impact on existing products, processes, and documentation.
• Support regulatory audits and inspections by coordinating required documents, responses, and compliance-related activities.

Requirements

• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, or a related discipline is mandatory.
• Minimum five years of experience in Quality Assurance, can consider candidates who have worked on manufacturing units and has handled market complaints.
• Strong knowledge of finished product specifications, analytical methods, and pharmaceutical laboratory testing practices.
• Working understanding of analytical method validation principles and regulatory requirements for laboratory testing.
• Ability to review analytical documentation and technical manufacturing data and coordinate effectively with R\&D, QC, QA, and regulatory teams.

Benefits

• Option to work from home or from office depending on operational requirements.
• Exposure to regulatory operations and pharmaceutical product submission processes across multiple markets.
• Opportunity to work closely with manufacturing, analytical laboratories, and regulatory teams.

Pay

₹400,000.00 - ₹600,000.00 per year

Work Location

In person