Packaging Manager

Biocon Biologics; Bengaluru; On-site; INR 2,500,000 - 5,500,000; Full time

Job summary

Biocon Biologics in Bengaluru, India, is seeking a Manager, Packing to lead daily to monthly packing operations, ensuring on-time production, quality, and compliance.

You will drive continuous improvement, oversee SOPs, CAPEX/OPEX budgeting for packing, lead a team, coordinate with SCM, Engineering, and QA to sustain GMP standards and optimize OEE.

Responsibilities

• Deliver the daily, weekly, and monthly packing plan in alignment with SCM, PM, and business priorities.
• Plan, schedule, and optimize production to maximize throughput, resources, and efficiency.
• Ensure targets are met with quality, compliance, cost, and on-time delivery.
• Drive continuous improvement to boost productivity, reduce waste, and improve OEE.
• Lead root cause analysis and implement sustainable corrective actions for process issues.
• Coordinate with Engineering and Maintenance for preventive and predictive maintenance.
• Prepare and manage departmental CAPEX and OPEX budgets for packing.
• Lead audits and regulatory readiness to ensure inspection readiness.

Job description

• 12-20 Years of manufacturing experience with packaging

Education

Key Responsibilities & Accountabilities – Manager, Packing

Operational Excellence

• Accountable for delivering the daily, weekly, and monthly packing plan in alignment with Supply Chain Management (SCM), Program Management, and business priorities.
• Accountable for planning, scheduling, and optimizing production activities to maximize throughput, resource utilization, and manufacturing efficiency.
• Ensure production targets are achieved while maintaining the highest standards of quality, compliance, cost, and delivery.
• Drive continuous improvement initiatives to enhance productivity, reduce waste, improve yields, and optimize overall equipment effectiveness (OEE).
• Lead resolution of manufacturing and process-related issues through structured root cause analysis and implementation of sustainable corrective actions.
• Partner with Engineering and Maintenance to ensure preventive and predictive maintenance programs minimize equipment downtime and production interruptions.

Quality & Compliance Leadership

• Accountable for ensuring all packing operations comply with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), corporate quality standards, and applicable regulatory requirements.
• Provide governance for execution, review, and approval of Batch Manufacturing Records (BMRs), Batch Packing Records (BPRs), and associated manufacturing documentation to ensure data integrity and compliance.
• Lead departmental compliance with Quality Management System (QMS) processes, including Change Controls, Deviations, Investigations, CAPAs, Effectiveness Checks, and Risk Assessments.
• Ensure quality events are investigated using scientific and risk-based approaches, with timely implementation of effective corrective and preventive actions.
• Establish a culture of inspection readiness and ensure sustained compliance through proactive monitoring and continuous improvement.

Documentation, Validation & Technical Governance

• Provide technical oversight for the preparation, review, approval, and lifecycle management of Standard Operating Procedures (SOPs), technical documents, protocols, reports, and controlled records.
• Accountable for preparation and approval of User Requirement Specifications (URS) for new equipment and systems supporting packing operations.
• Lead qualification and validation activities for new and existing equipment, ensuring compliance with applicable regulatory and validation requirements.
• Ensure timely review and approval of qualification and validation documentation, including:
• Change Control Records (CCR)
• System Assessments
• Quality Risk Assessments
• Design Qualification (DQ)
• Factory Acceptance Testing (FAT)
• Site Acceptance Testing (SAT)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Requalification and Decommissioning
• Validation Summary Reports
• Traceability Matrix
• Electronic Records and Electronic Signatures (ERES) validation documentation

People Leadership & Capability Development

• Lead, coach, and develop the packing organization to build a high-performing, quality-focused, and accountable team.
• Establish clear roles, responsibilities, and performance expectations for direct reports and ensure effective deployment of departmental resources.
• Drive workforce capability by identifying competency gaps, developing training plans, and ensuring completion of role-based and competency-based training.
• Qualify departmental trainers and ensure the effectiveness of training programs through periodic assessments.
• Maintain departmental organization structure and Learning Management System (LMS) role assignments to support compliance and operational effectiveness.
• Foster a culture of ownership, engagement, continuous learning, and operational excellence.

Project & Asset Management

• Lead capital equipment projects for the packing function from concept through qualification, commissioning, and operational handover.
• Partner with Procurement, Engineering, Quality, and external vendors for equipment selection, technical evaluation, procurement, installation, and qualification.
• Accountable for preparation and management of departmental CAPEX and OPEX budgets to support strategic and operational objectives.

Audit & Regulatory Readiness

• Lead departmental preparedness for internal, customer, and regulatory inspections and audits.
• Ensure timely and effective closure of audit observations through robust corrective and preventive action plans.
• Represent the Packing function during inspections, audits, and cross-functional quality governance forums.
• Owning audit observations

Safety, Environment & Operational Risk

• Champion a strong Environment, Health & Safety (EHS) culture by ensuring compliance with all safety, health, and environmental requirements.
• Ensure workplace housekeeping, equipment cleanliness, and operational controls always meet GMP and EHS standards.
• Promote proactive risk identification and mitigation to ensure safe, reliable, and compliant manufacturing operations.

Performance Management & Governance

• Establish, monitor, and review departmental Key Performance Indicators (KPIs) related to Safety, Quality, Delivery, Cost, Compliance, Productivity, and People Development.
• Analyze operational trends and performance metrics to identify improvement opportunities and drive data-based decision making.
• Provide regular operational and compliance updates to senior leadership, highlighting risks, mitigation plans, and business performance.
• Drive cross-functional collaboration to achieve departmental, site, and organizational objectives while fostering a culture of accountability and operational excellence.