Walk-in | Engineer/ Deputy Manager - Quality

Polymed; Faridabad District; On-site; INR 600,000 - 900,000; Full time

Job summary

Polymed in India is seeking a validation professional to plan and execute validation activities for processes, equipment, and products. The role involves preparing validation protocols, reviewing documentation, and ensuring compliance with ISO 13485 and GMP standards.

You will perform IQ, OQ, and PQ for equipment and manufacturing processes, and support qualification of new products. In this position you will analyze validation data, generate summary reports, investigate failures, and drive

Responsibilities

• Plan and execute process, equipment, and product validation activities.
• Prepare and review validation protocols, reports, and documentation.
• Perform IQ, OQ, and PQ for equipment, utilities, and manufacturing processes.
• Support process qualification and validation of new products.
• Ensure compliance with ISO 13485, GMP, and regulatory requirements.
• Analyse validation data and prepare summary reports.
• Investigate validation failures and implement corrective actions.
• Coordinate with Production, Quality, Engineering, and Regulatory teams.
• Maintain validation master plans and validation records.
• Support audits and regulatory inspections.
• Drive continuous improvement in validation and qualification activities.
• Ensure validated processes remain in a state of control through periodic review.

Job description

Role & responsibilities

• Plan and execute process, equipment, and product validation activities.
• Prepare and review validation protocols, reports, and documentation.
• Perform IQ, OQ, and PQ for equipment, utilities, and manufacturing processes.
• Support process qualification and validation of new products.
• Ensure compliance with ISO 13485, GMP, and regulatory requirements.
• Analyse validation data and prepare summary reports.
• Investigate validation failures and implement corrective actions.
• Coordinate with Production, Quality, Engineering, and Regulatory teams.
• Maintain validation master plans and validation records.
• Support audits and regulatory inspections.
• Drive continuous improvement in validation and qualification activities.
• Ensure validated processes remain in a state of control through periodic review.