Packaging Associate

Overview

Supervise packing operations, including material segregation and dispensing verification, shift production, process and documentation compliance, cleaning clearances, and training of operators, in line with cGMP and company procedures.

What you'll do

• Ensure segregation, storage and movement of dispensed materials.
• Verify dispensed materials before the start of operation.
• Perform environmental monitoring as per product specifications.
• Execute production activities in a shift by managing available resources to achieve production targets.
• Maintain standard process parameters as per BMRs, BPRs and other supporting documents to achieve production targets and maintain quality.
• Verify online documentation against electronic data in the PLC, including events and alarms during the process, and verify specified versus actual data recording practices.
• Initiate Type A and Type B cleaning line clearances.
• Perform supervisor activities and non-process area maintenance on requirement basis.
• Minimize documentation errors on the shop floor.
• Perform gap analysis of existing SOPs for further improvement.
• Develop multi-skilled personnel in the department for equipment operation and documentation.
• Ensure key points and decisions are regularly summarized and that critical steps are understood by technical staff throughout meetings.
• Prepare and distribute a detailed agenda before meetings, outlining key topics and objectives.
• Provide daily training to operators on CAPA, recent events, DI, GDP and other relevant topics to maintain 100% compliance.
• Maintain the area in a presentable condition at all times.
• Coordinate with CFT.
• Ensure maintenance and cleanliness of critical utilities (if applicable) as per procedures.
• Ensure all manufacturing operations and related documentation are updated as per BMR, BPR, SOP and cGMP, and review BMRs and BPRs.
• Be responsible for validation, qualification and calibration of processes or equipment, and handling of all QMS documentation.
• Be responsible for training of new joiners and scheduled and unscheduled department training.
• Work with production teams to ensure cost-effective, high-quality and timely delivery of products.
• Carry out activities as assigned by supervisor, shift in-charge and management based on company requirements.
• Monitor and minimize spillage and in-process rejection shift-wise, and take part in yield improvement programs.
• Perform in-process checks in manufacturing and packing operations.
• Submit swab sample requests to QC.
• Perform BMR and BPR reconciliation, batch review and closing.
• Retrieve executed documents for QA.
• Ensure completion of equipment and instrument calibration and maintenance as per schedule.
• Ensure area fumigation is completed within the timeline.
• Oversee and guide critical processes such as recipe loading, binder addition, kneading, loading, AWC and gun validation.
• Be especially vigilant during manual operations where electronic data is unavailable, and witness critical activities such as granulation and sampling.
• Review and approve all master documents.
• Drive operational excellence by analyzing current operational processes, identifying inefficiencies and implementing changes to improve productivity and reduce costs.

Details

• Location: Pudupakkam, India.