Assistant Manager

Description:

The Assistant Manager – Production is responsible for supervising, coordinating, and supporting daily manufacturing activities for medical devices, including active and non-active medical devices such as catheter-related products, within ISO Class 5–8 cleanrooms. The role ensures compliance with ISO 13485, regulatory requirements, approved work instructions, and production schedules. The AM Production assists in resource allocation, documentation control, in-process quality checks, and continuous improvement initiatives to maintain efficient, safe, and compliant production operations.

Key Responsibilities:

• Supervise day-to-day production activities across assigned cleanrooms (ISO 5, 7, and 8).

• Ensure production targets, batch plans, and work orders are executed as per schedule.

• Monitor manpower utilization, shift functioning, and equipment readiness.

• Ensure correct execution of SOPs, Batch Manufacturing Records (BMRs), and Device History Records (DHRs).

• Assist in material issuance requests and coordinate with Supply Chain for inventory requirements.

• Ensure all production activities adhere to ISO 13485, GMP, and regulatory standards.

• Enforce cleanroom gowning, hygiene, movement, and contamination control practices.

• Conduct in-process inspections and ensure timely escalation of nonconformities or deviations.

• Support Quality Assurance in investigations, CAPA implementation, and document revisions.

• Ensure real-time, accurate completion of production logs, equipment forms, and traceability records.

• Support execution of IQ, OQ, and PQ activities for new and existing equipment.

• Coordinate preventive maintenance, calibration, and readiness checks with Engineering/Maintenance teams.

• Identify process issues, bottlenecks, or equipment deviations and propose corrective actions.

• Support process improvements to enhance output, yield, and efficiency.

• Prepare daily and weekly production reports for submission to GM Production/CPO.

• Ensure batch documentation, logbooks, checklists, and registers are updated and compliant.

• Assist in maintaining up-to-date SOPs, WIs, and training documentation for production processes.

• Supervise production operators, technicians, and support staff.

• Conduct on-the-job training for new employees and evaluate competency.

• Ensure all production personnel follow workplace safety and cleanroom discipline.

• Foster teamwork, communication, and continuous improvement mindset within the team.

• Work closely with Quality, R&D, Engineering, Supply Chain, and Warehouse teams.

• Support production scale-up, technology transfer, and introduction of new product lines.

• Assist in supporting internal/external audits (ISO, FDA, customer audits).

Qualification: Bachelor’s or Master’s degree in Biomedical/Electrical/Mechanical or other related Engineering or technical field.

Experience: 2-3 years’ experience in medical device, pharmaceutical, or cleanroom-based production, with at least 1 years in a leadership role.