Vivek Tomar

Deviation Management & CAPA: Ensuring all manufacturing deviations are investigated, documented, and that Corrective and Preventive Actions (CAPA) are closed on time.

Right-First-Time (RFT) Rate: Maximizing the percentage of batches produced correctly, without rework, defects, or deviations.

Audit Readiness: Maintaining high audit readiness scores for regulatory inspections (FDA, EMA, WHO).

SOP Adherence: Ensuring strict compliance with Standard Operating Procedures (SOPs) and batch manufacturing records (BMR).

Production Schedule Adherence: Ensuring production lines meet the scheduled targets to avoid delays in product delivery.

Overall Equipment Effectiveness (OEE): Monitoring machine availability, performance, and quality, targeting high OEE for tableting, capsule, or liquid lines.

Batch Cycle Time: Reducing the total time taken to complete a production batch, from raw materials to finished product.

Capacity Utilization: Optimizing the use of machines and personnel to prevent idle time and bottlenecking.

Manufacturing Cost per Unit: Tracking and reducing the total cost per unit (materials, labor, energy, waste).

Scrap/Waste Reduction: Minimizing rejected material, product loss during formulation, and packaging waste.

Batch Yield: Maximizing the yield of drug substances and products to ensure profitability.

Continuous Improvement: Implementing Lean Manufacturing, 5S, or Six Sigma initiatives to enhance productivity.

On-Time-In-Full (OTIF) Delivery: Ensuring that produced drugs are delivered to the warehouse or customers on schedule.

Inventory Control: Managing Work-in-Process (WIP) and monitoring raw material consumption against production requirements.

Safety Performance: Maintaining zero-accident workplaces, enforcing safety protocols (OSHA/local regulations), and minimizing lost workdays.

Training and Competency: Ensuring 100% compliance with training requirements for all operators regarding safety and GMP.

Team Leadership: Building high-performing teams, promoting cross-training, and improving staff productivity.

Equipment Uptime: Maximizing uptime through effective preventive and predictive maintenance schedules.

Changeover Time: Reducing the time taken to retool or clean machinery between different product batches

• Managed and motivated employees to be productive and engaged in work.
• Accomplished multiple tasks within established timeframes.
• Maximized performance by monitoring daily activities and mentoring team members.
• Enhanced customer satisfaction by resolving disputes promptly, maintaining open lines of communication, and ensuring high-quality service delivery.

• Currently handling of tablet facility, producing approx.400 million tablets per months.
• Managing the entire gamut of Manufacturing Operations including resolving the problems and updating the same periodically with the actions to be undertaken throughout.
• Preparation of daily production report and monthly planning schedule.
• Preparation and review of protocols and BMRs for new products & batch size increase.
• Handling of QMS i.e. changes controls, Deviations, Investigations, Risk assessment and CAPA in track wises system.
• Preparation & implementation of protocol, SOPs gap-assessment.
• Executing commissioning & qualification of new equipment and Machines.
• Acting as a core team member for machine automation and process optimization.
• Representative of team for implementation of quality ideas at shop floor.
• Preparation of various commissioning, miscellaneous and other qualification study related protocol and its report.
• Expertise in day to day troubleshooting at shop floor with clear understanding of long term remediation of products.
• Supporting & executing continuous improvement actions and projects such as improving process capability, minimize wastes of materials, yield improvement.

• Creation of process order in SAP, Creation of BOM in SAP.
• Implementation of production plan at shop floor level received from planning department.
• Batch size optimization for reducing the down time and increase the machine runtime, which leading to reduction in production and analysis cost.
• Preparation of SOP and protocols.
• To ensure the cGMP and SOP's compliances.
• Giving operational assistance to the operator for smooth running of the machine
• Supporting & executing continuous improvement actions and projects such as improving process capability, minimize wastes of materials, yield improvement.
• Coordinating cross-functionally with Manufacturing, Procurement, QC, engineering, Validation RA, PDL, so on to provide timely support to Supply Chain while ensuring quality & compliance.
• Supervising granulation, Compression and coating area by following all the system and operational sop's, making the SAP entry of the same batch.

• Execution of production plan as per schedule.
• Involved in multiple formula harmonization.
• Batch size optimization for reducing the down time and increase the machine runtime, which leading to reduction in production and analysis cost.
• Qualification of FBP equipment.
• Preparation of SOP and protocols.
• To ensure the cGMP compliances and SOP's compliances.
• Giving operational assistance to the operator for smooth running of the machine.
• Implementation of production plan at shop floor level received from planning department.
• Supervising granulation by following all the system and operational sop's, making the SAP entry of the same batch.

• Preparation of BMR, Sop's, packing validation and verification protocol.
• Creation of process order in SAP, Creation of BOM in SAP.
• To ensure the cGMP compliances and SOP's compliances
• Implementation of production plan received from supply chain with occupying maximum number of machines.
• Maintaining and putting effort to increase the OEE of machines.
• Putting Effort to decrease the Plant cycle time of process.
• Core member of implementing the eDMD, eTMS in unit - II.
• Manager Model concept working (In manager model concept we are identifying the busiest machine for the month having more number of change over. In this we are having more vigilance towards the machine during changeover against standard changeover time).

• Installation of RMG, FBD and Solace Compression machine in new project plant.
• Supervising granulation by following all the system and operational sop's.
• Reconciliation of Tablets and Granules as per BMR.
• To give cGMP, SOP's and on job training to all the subordinates and workers.
• To ensure the cGMP compliances and SOP's compliances periodically.
• Online Documentation includes Production System entries and other applications of Such as preparation of BMR'S.
• To prepare and submit daily reports to section in charge.

• Supervising granulation by following all the system and operational sop's.
• Reconciliation of Tablets and Granules as per BMR.
• To give cGMP, SOP's and on job training to all the subordinates and workers.
• To ensure the cGMP compliances and SOP's compliances periodically.
• Online Documentation includes Production System entries and other applications of Such as preparation of BMR'S.
• To prepare and submit daily reports to section in charge.