Assistant Manager, Quality Assurance

Job Summary

We are seeking an Assistant Manager, Operational Quality Assurance to ensure the highest standards of quality, compliance, and product integrity across manufacturing operations. This role will be responsible for batch release activities, in-process quality assurance, quality systems management, equipment qualification oversight, deviation investigations, and CAPA implementation. Working closely with Manufacturing, QC, Engineering, and Maintenance teams, you will ensure compliance with cGMP, regulatory expectations, and internal quality standards while driving continuous improvement initiatives across the site.

Location: Dharuhera, India

What you will get

• Opportunity to play a critical role in ensuring product quality and regulatory compliance in a GMP-regulated manufacturing environment.
• Exposure to end-to-end quality operations including batch release, IPQA, quality systems, investigations, and audit readiness.
• Collaborative work environment involving cross-functional engagement with Production, Quality Control, Engineering, Maintenance, and Project teams.
• Opportunity to lead and contribute to continuous improvement initiatives that enhance product quality, operational efficiency, and compliance performance.
• Professional development within a global quality culture focused on quality excellence, customer satisfaction, and regulatory compliance.

What you will do

• Review and approve Work Order Packages (WOPs), production records, and associated batch documentation to support timely product release.
• Review Quality Control data and verify the accuracy of Certificates of Analysis (CoAs) prior to customer distribution.
• Perform batch disposition and release activities within SAP following comprehensive quality review.
• Prepare, review, and approve quality documents including SOPs, Validation Master Plans (VMPs), qualification protocols, and related records.
• Oversee equipment qualification and calibration activities to ensure compliance with quality and regulatory requirements.
• Support and conduct In-Process Quality Assurance (IPQA) activities on the manufacturing floor to ensure adherence to GMP standards.
• Lead investigations related to deviations, incidents, OOS/OOT events, and manufacturing quality issues through effective root cause analysis.

What we are looking for

• Strong experience of 7-10 years in Quality Assurance within pharmaceutical, healthcare, life sciences, or regulated manufacturing environments.
• Sound knowledge of cGMP requirements, Quality Management Systems (QMS), ICH guidelines, and regulatory compliance expectations.
• Experience in batch record review, batch release, deviation management, CAPA, change control, qualification, and validation activities.
• Demonstrated ability to perform root cause investigations and drive effective quality improvements.
• Experience supporting audits, inspections, and regulatory compliance programs.
• Strong analytical, problem-solving, and decision-making skills with attention to detail.
• Excellent communication and stakeholder management skills with the ability to collaborate effectively across functions.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.