Hrushikesh sankhe

Manufacturing Technical Specialist

• Job Details:Orchestrated end-to-end pharmaceutical manufacturing processes, including formulation, blending, compression, and coating, leading to a 15% increase in production throughput while ensuring zero non-compliance incidents. Spearheaded in-process quality checks and equipment calibrations, reducing defect rates by 8% and ensuring 100% adherence to FDA, GMP, and CGMP standards, securing a successful audit outcome. Redesigned batch record management and SOP documentation, improving compliance reporting accuracy by 20% and accelerating regulatory approval timelines by 10%. Liaised with R&D, quality control (QC), and regulatory affairs to facilitate smooth product transfers and process validations, resulting in a 98% first-pass approval rate for new product launches. Analyzed and rectified recurring operational inefficiencies, improving on-time delivery by 10% and ensuring seamless production flow during peak demand periods. Led the implementation of new equipment and process upgrades, reducing equipment downtime by 7% and extending machinery lifespan through proactive preventive maintenance strategies. Applied lean six sigma methodologies, cutting cycle times by 12%, optimizing resource allocation, and enhancing manufacturing efficiency. Conducted GMP training sessions for production teams, improving SOP adherence by 30% and boosting overall operational efficiency. Managed deviation investigations implemented corrective and preventive actions (CAPA) and ensured timely closure of change controls. Utilized data-driven decision-making, monitoring production metrics through databases and spreadsheets to drive continuous process improvements and maintain compliance. Ensured seamless shift transitions and workload balancing, mitigating production bottlenecks, and achieving 10% improvement in on-time delivery during peak demand periods. Collaborated with warehouse teams to optimize raw material usage, tracking, and storage, reducing waste, and ensuring efficient resource utilization.

Manufacturing Operations Specialist

• Job Details:Redesigned manufacturing workflows, leading to measurable improvements in production efficiency and a noticeable increase in product consistency. Introduced refinements to pharmaceutical processes and equipment, resulting in a 20% boost in performance and a higher adherence to quality specifications. Shared technical expertise with production teams, strengthening knowledge transfer and improving overall workforce proficiency. Handled deviation reports and collaborated with QA for timely CAPA implementation and root cause analysis. Carried out WHO audit preparations with close attention to detail, achieving full compliance while minimizing equipment downtime by 20% through systematic maintenance planning. Trained and mentored production staff, strengthening workforce proficiency, reducing process errors, and improving knowledge transfer on complex manufacturing protocols. Ensured compliance with safety and regulatory standards, adhering to company policies and CGMP requirements.

Manufacturing Specialist

• Job Details:Supervised mixing and compression operations, maintaining process accuracy and improving product uniformity by 10%. Coordinated shift transitions, ensuring continuous production flow, and minimizing operational delays. Conducted batch record reviews, identifying, and correcting discrepancies, reducing compliance errors by 12% and maintaining regulatory adherence. Assisted in cross-functional quality control initiatives, enforcing stricter adherence to protocols, and leading to a 10% reduction in batch failures. Adjusted tablet compression and granulation machine parameters based on process requirements, achieving a 35% reduction in production bottlenecks, and increasing overall throughput. Analyzed production reports to detect trends and deviations, contributing to improved efficiency in formulation processes. Managed warehouse operations, including inventory control, raw material handling, order fulfillment, and cycle counts, ensuring uninterrupted production supply.