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