06 Aug
|
BIOCON BIOLOGICS
|
Bengaluru
06 Aug
BIOCON BIOLOGICS
Bengaluru
Experience
12-20 Years of manufacturing experience with packaging Education
Bachelor's degree, master's degree.
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 Valuable 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 current 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.
📌 Packaging Manager (Bengaluru)
🏢 BIOCON BIOLOGICS
📍 Bengaluru