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Packaging Manager

Biocon Biologics

BangaloreFull-timeMid LevelOn-site

Job Description

Experience

  • 12-20 Years of manufacturing experience with packaging


Education

  • Bachelor's degree, master's degree.


Key Responsibilities & Accountabilities โ€“ 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)
  • Installation Qualification (IQ)
  • 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.


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