A pharmacy professional having around 16 years of experience in Manufacturing & Packing Operations from reputed Pharma organizations like Aurobindo Pharma Ltd, Strides Pharma Science Limited, Shasun Pharmaceutical Ltd and Lee Pharma Limited. Currently working as Sr. Manager- Production at Aurobindo Pharma limited Naidupeta AP.
Key Result Areas:
❖ Responsible for Production activities (Tablets and Hard gelatin capsules) of Aurobindo Pharma Limited.
❖ Production planning & deliveries based on weekly, monthly and quarterly targets for Oral Solids Dosage forms.
❖ Managing the production operations in the organization to ensure timely completion of production targets within pre-designated time and cost parameters
❖ Formulating the SOP (Standard Operating Procedures), implementing effective techniques to bring efficiency, improve quality standards and achieve maximum cost savings
❖ Preparing production & dispatch plans, organizing resources to meet the business requirement; evaluating production deviations, investigating the critical deviations and maintain records for the same;executing manufacturing of process validation, process optimization, EB and Commercial batches
❖ Dealing a team of around 230 members for Manufacturing Targets with focus on Safety, Quality, Service and Cost
❖ Ensuring that finished drug products are designed and developed in a way that takes account of the requirements of GMP
❖ Enforcing a culture of lean sigma manufacturing and continuous improvement while providing operational leadership
❖ Promoting (Zero AWD) Zero Accidents, Waste & Defect free operations mindset within teams
❖ Setting-up & completing various projects in coordination with Cross-functional Teams to develop entire process from scratch to ensure streamlined production activities
❖ Imparting training with respect to on-the-job training, GMP, Safety, Hygiene, application and principles of production and maintenance of industrial relations
❖ Mentoring, motivating & monitoring the performance of team members to ensure efficiency in process operations
❖ Responsible for audits & compliance for the department.
❖ Ensure that cGMP practices are fully adhered.
❖ Team management and Manpower deployment.
❖ Quality Management System - Deviations, change controls, CAPA and incidents through SAP &Track wise system.
❖ Trouble shooting with respect to Compression, Capsule filling and Coating process.
❖ Timely review of yields, recoverable and losses in the process.
❖ Evaluation of safety needs for new products and implementation of recommendations.
❖ Involved in projects for the OEE improvement, cost improvement, process improvement and yield improvements.
Equipment Managed
❖ Tablet compression machines
o GEA Modul-S
o GEA Modul-D
o Sejong
o Fette 3200i, P- 3030 & 1200i
o Conventional Compression machines
❖ Tablet coating pans – Neo coater & Ganson coater, Glatt & Bectochem
❖ Capsule filling machines- AF 25, AF 90,AF 150, ZRO 90 ZRO 200& Bosch
❖ Auto inspection machine – Sensum & Proditec
❖ Thickness sorting machine.
Audit& Compliance
❖ Handling of all regulatory & customer audits
❖ Involved in preparation and submission of compliance reports
Projects Handled
Efficiency Improvement Projects
❖ Capacity enhancement by improving OEE
❖ Productivity and process improvements.
❖ Improvement in supplies & deliveries month to month basis at module level.
❖ Active participation in projects for Yield improvements & quality improvement.
❖ Implementation of Multi-blend concept for increasing batch size.
Cost Reduction/Efficiency Improvement Projects
❖ Implementation of e-BMR & e-logbooks.
❖ Implementation of CIP process for identified products.
❖ Revision and harmonization of all equipment cleaning and operational procedures with respect to alarms generated in the machine.
Highlights:
❖ Successfully reduced the product changeover duration for critical compression equipment in the part of OPERA.
❖ Successfully implemented e-log book & e-BMR for identified products.
❖ Optimization of Bilayer tableting process with improved yield.
❖ Steered efforts in managing Tablet Compression, Capsule filling and coating Process.