Job Detail

Job Description

Responsible for authorization of Production related documents.

Maintain the documents as per systems related to cGMP for various statutory and regulatory audits and inspections.

To actively participate in process validation as well as cleaning validation activity and environmental monitoring as per plan.

Responsible for the Batch Manufacturing Records review in GMP compliance norms.

Monitor the Equipments breakdown as well as utility maintenance in line with the engineering department.

Monitor the working of the Assist. Manager and their respective production team. to take corrective action as an when required for the betterment of the production department.

To guide the safety officer for achieving the desired safety objective in relation to the plant.

Handling of external audits along with QA department.

Ensure Safety, Health and hygiene is sustained in the plant by monitoring and taking action on the audit reports.

Review SOPs as per the QMS guideline.

Internal Audits of different departments as per internal audit calendar.

Ensure proper maintenance & housekeeping in the production department.

Induction training in the new join in the department & on the job training to department staff.

New product trials and technology transfer adoption as per management guideline.

Manufacture quality products as per the requirement of the customers and ensure timely delivery for the dispatch of the product in close coordination with others department.

Review and study product parameters, reduce time cycles, improve yields, reduce energy conservation, bring down product cost, increase profitability and ensure optimum utilization of the plant capacity, Reducing production cost by implementing right first time (RFT)/ failure reduction with effective root cause analysis and CAPA implementation.

Proactive disposal of spent solvent and scrap to reduce hazard inside the premises.

Focus on Energy Conservation.

Skills Required

• Chemical
• Production Manager
• Production Management
• Batch Manufacturing Records (BMR)
• cGMP Compliance
• Process Validation
• Cleaning Validation
• Environmental Monitoring
• Equipment Breakdown Management
• Utility Maintenance
• Team Supervision
• Corrective Actions
• Safety Management
• Regulatory Audits
• QA Collaboration
• Internal Audits
• SOP Review
• Housekeeping Management
• Induction Training
• On-the-job Training
• Technology Transfer
• New Product Trials
• Customer Requirement Alignment
• Energy Conservation
• Root Cause Analysis (RCA)
• CAPA Implementation (Corrective and Preventive Action)
• Waste Disposal Management