Assistant Manager - Quality Assurance

Role & responsibilities

Monitor and strengthen In-Process Quality Control (IPQC) activities across manufacturing processes and ensure adherence to approved specifications and procedures.

• Review Batch Manufacturing Records (BMR), Batch Packing Records (BPR), inspection records, and other manufacturing documentation, and support timely resolution of documentation/process-related issues.

• Manage Artwork and IFU activities, including initiation, review, approval, proofreading, version control, change implementation, and maintenance of approved artwork records.

• Coordinate with Regulatory, Marketing, Production, R&D, and other stakeholders for new/revised artwork, IFUs, labels, packaging materials, and customer-specific requirements.

• Support preparation and maintenance of APEX/QMS documents, including Validation Master Plan/File, validation protocols and reports, Site Master File, Product Validation/Master Reports, Quality Agreements, and Quality Policy.

• Review and support closure of deviations, investigations, CAPA, complaints, Change Controls, and requalification activities related to manufacturing and quality operations.

• Prepare, review, and update SOPs, procedures, work instructions, protocols, and other QA documents as required.

• Support internal, customer, and regulatory audits, including audit preparation, execution, observation response, and CAPA follow-up.

• Ensure adherence to approved QMS procedures and regulatory requirements across QA, QC, Manufacturing, Warehouse, Engineering, and other relevant functions.

• Support compliance with ISO 9001, ISO 13485, EU MDR 2017/745, I-MDR, US FDA 21 CFR Part 820, and applicable customer requirements.

• Maintain effective artwork records, IPQC records, batch documentation, and quality records in accordance with document control requirements.

• Identify process and documentation gaps and support continuous quality improvement initiatives.