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Location: Dharuhera, India
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.
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.
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.
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.
At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.
