16 Sep
|
BIOCON BIOLOGICS
|
Bengaluru
16 Sep
BIOCON BIOLOGICS
Bengaluru
Job DescriptionExperience
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- 12-20 Years of manufacturing experience with packaging
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nEducation
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- Bachelor's degree, master's degree.
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nKey Responsibilities & Accountabilities – Manager, Packing
NOperational Excellence
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- Accountable for delivering the daily, weekly, and monthly packing plan in alignment with Supply Chain Management (SCM), Program Management, and business priorities.
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- Accountable for planning, scheduling, and optimizing production activities to maximize throughput, resource utilization, and manufacturing efficiency.
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- Ensure production targets are achieved while maintaining the highest standards of quality, compliance, cost, and delivery.
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- Drive continuous improvement initiatives to enhance productivity, reduce waste, improve yields, and optimize overall equipment effectiveness (OEE).
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- Lead resolution of manufacturing and process-related issues through structured root cause analysis and implementation of sustainable corrective actions.
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- Partner with Engineering and Maintenance to ensure preventive and predictive maintenance programs minimize equipment downtime and production interruptions.
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nQuality & Compliance Leadership
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- Accountable for ensuring all packing operations comply with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), corporate quality standards, and applicable regulatory requirements.
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- 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.
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- Lead departmental compliance with Quality Management System (QMS) processes, including Change Controls, Deviations, Investigations, CAPAs, Effectiveness Checks, and Risk Assessments.
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- Ensure quality events are investigated using scientific and risk-based approaches, with timely implementation of effective corrective and preventive actions.
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- Establish a culture of inspection readiness and ensure sustained compliance through proactive monitoring and continuous improvement.
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nDocumentation, Validation & Technical Governance
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- Provide technicaloversight for the preparation, review, approval, and lifecycle management of Standard Operating Procedures (SOPs), technical documents, protocols, reports, and controlled records.
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- Accountable for preparation and approval of User Requirement Specifications (URS) for new equipment and systems supporting packing operations.
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- Lead qualification and validation activities for new and existing equipment, ensuring compliance with applicable regulatory and validation requirements.
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- Ensure timely review and approval of qualification and validation documentation, including:
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- Change Control Records (CCR)
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- System Assessments
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- Quality Risk Assessments
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- Design Qualification (DQ)
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- Factory Acceptance Testing (FAT)
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- Site Acceptance Testing(SAT)
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- Installation Qualification (IQ)
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- Operational Qualification (OQ)
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- Performance Qualification (PQ)
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- Requalification and Decommissioning
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- Validation Summary Reports
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- Traceability Matrix
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- Electronic Records and Electronic Signatures (ERES) validation documentation
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nPeople Leadership & Capability Development
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- Lead, coach, and develop the packing organization to build a high-performing, quality-focused, and accountable team.
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- Establish clear roles, responsibilities, and performance expectations for direct reports and ensure effective deployment of departmental resources.
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- Drive workforce capability by identifying competency gaps, developing training plans, and ensuring completion of role-based and competency-based training.
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- Qualify departmental trainers and ensure the effectiveness of training programs through periodic assessments.
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- Maintain departmental organization structure and Learning Management System (LMS)
role assignments to support compliance and operational effectiveness.
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- Foster a culture of ownership, engagement, continuous learning, and operational excellence.
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nProject & Asset Management
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- Lead capital equipment projects for the packing function from concept through qualification, commissioning, and operational handover.
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- Partner with Procurement, Engineering, Quality, and external vendors for equipment selection, technical evaluation, procurement, installation, and qualification.
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- Accountable for preparation and management of departmental CAPEX and OPEX budgets to support strategic and operational objectives.
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nAudit & RegulatoryReadiness
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- Lead departmentalpreparedness for internal, customer, and regulatory inspections and audits.
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- Ensure timely and effective closure of audit observations through robust corrective and preventive action plans.
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- Represent the Packing function during inspections, audits, and cross-functional quality governance forums.
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- Owning audit observations
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nSafety, Environment & Operational Risk
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- Champion a strongEnvironment, Health & Safety (EHS) culture by ensuring compliance with all safety, health, and environmental requirements.
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- Ensure workplace housekeeping, equipment cleanliness, and operational controls always meet GMP and EHS standards.
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- Promote proactive risk identification and mitigation to ensure secure, reliable, and compliant manufacturing operations.
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nPerformance Management & Governance
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- Establish, monitor, and review departmental Key Performance Indicators (KPIs) related to Safety, Quality, Delivery, Cost, Compliance, Productivity, and People Development.
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- Analyze operational trends and performance metrics to identify improvement opportunities and drive data-based decision making.
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- Provide regular operational and compliance updates to senior leadership, highlighting risks, mitigation plans, and business performance.
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- Drive cross-functional collaboration to achieve departmental, site, and organizational objectives while fostering a culture of accountability and operational excellence.
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📌 Hiring: Packaging Manager (Bengaluru)
🏢 BIOCON BIOLOGICS
📍 Bengaluru