Assistant Manager - Quality Assurance

Healthium Medtech Limited; Bengaluru; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Healthium Medtech Limited in Bengaluru is seeking a QA professional to strengthen IPQC activities, review manufacturing records, and manage artwork/IFU-related tasks. You will coordinate with cross-functional teams to ensure compliance with approved specifications and procedures, while supporting audits and CAPA.

A strong background in GMP and QA/QC within medical device or pharma environments is required. Role emphasizes documentation control, deviation closure, change control, and maintaining

Qualifications

• Bachelors in Science or Pharmacy related field.
• Guidance on QA/QC processes and GMP.
• Familiarity with ISO 13485, EU MDR, FDA norms preferred.

Responsibilities

• Monitor and strengthen IPQC activities across manufacturing processes.
• Review and resolve documentation and process issues in BMR/BPR and records.
• Coordinate with Regulatory, Marketing, Production, R&D for artwork, IFU, labels and packaging.
• Support audits, CAPA, deviations, investigations, change controls, and requalification activities.
• Prepare and update SOPs, work instructions, and QA documents as required.
• Ensure adherence to QMS procedures across QA, QC, Manufacturing, and Warehouse.

Skills

IPQC

Quality control

Document control

GMP

Education

B.Sc./Diploma in Science or Pharmacy

Job description

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.