SANTOSH BEHERA

A competent approved FDA professional with nearly 22 years of experience in Production Operations, Process Management, Audit, Compliance and Team Management & Quality Control & Assurance. Currently working with Hindustan Unilever Ltd., as 2P-unit in charge, Deft in developing quality metrics and assess trends for product or process implications, developing & implementing improvements to existing sample and data analysis techniques. Skilled in carrying out various tests and inspection for various processes and checking the quality standards of final products. Rich experience in Production & Quality Assurance and Total Quality Management (TQM). Adept at preventive maintenance of all machines during the operation of Injection section; monitoring water management system for RO, WFI and chlorination plant. Ability to communicate effectively at all levels of the development process. Strong interpersonal, verbal, and written communication skills. A comprehensive background in both tactical management and strategic planning. Committed to increasing production and the efficiency of overall operations. Demonstrated success in improving yield, saving energy and managing hazardous chemicals and other environmental concerns. Well-versed in customer needs, market trends and sales practices. Adept at managing teams, directing operations and increasing efficiency. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.

• Hindustan Unilever Ltd., 09/10, present, Unit in charge of 2P unit (HUL) at Odisha
• Ozone Pharmaceuticals Ltd., Guwahati, 09/02, 08/10, Production Manager of Small Volume Parenteral, Tablet, Capsules and Ointments

• Production Management
• Quality Assurance
• Tests & Inspection
• Technical Support
• Maintenance Operations
• Root Cause Analysis
• Operations Management
• Training & Development
• MIS / Reporting
• Process Management
• Liaison & Coordination, Team Management

Spearheading a wide gamut of activities encompassing. Planning the production activities and implementing plans with a view to ensure timely accomplishment of production targets within the cost parameters. Determining the future needs and production capacity for producing required quantities of items and within financial costs. Preparing & maintaining entire production related reports to apprise the top management. Coordinating with other related functions for smooth & uninterrupted running of all production activities. Responsible for zero incident in safety. Manpower reduction with automation project. Preparing Standard Operating Procedures and ensuring complete in-process quality control and continuous improvement in process capabilities. , Involved in the preparation & review of SOPs & BPRs; updating of DPR on daily basis; timely completion of process validation; maintaining & controlling deviations in department. Liaising with government official for FDA approval for new products Accountable for achieving all machine OEE; WCM implementation; new machine installation & commissioning. Defining & implementing the quality standards & structured processes / quality plans for various production operations. Preparing monthly quality analysis report and maintaining documents as per norms. Generating daily product quality report & sending it to factory manager; responsible for reporting about Non-conforming Products to In-charge Q.C. & Central QA. Looking after production related tasks including online inspection, final inspection to minimize the line rejections and final stage rejections . Responsible for prioritizing quality assurance responsibilities based on the integration of new designs and products into current production schedule. Overseeing and optimizing the manufacturing processes & troubleshooting problems in coordination with other departments for new product development & improving efficiency. Effectively conducting supplier & 3P audits periodically to ensure all quality standards are maintained; internal audits and monitoring process stage wise inspection to reduce rejections in lines.  Aligning raw material & packaging material specification as per interspace requirement in SAP or PLM Carrying out pareto analysis of defects category wise and preparing proper action plan in conjugation with the concerned team to reduce the overall Depot defects. Driving the team for overall TPM/WCM improvements. Setting direction, energizing, mentoring, coaching, motivating, guiding, and supporting teams. Providing awareness’ training among the employees. Developing, managing, and monitoring the performance of multi-skilled large work force and conceptualizing need-based training programs for performing operations. Creating and sustaining a dynamic environment that fosters development opportunities and motivates high performance amongst team members.

• QMS Internal Auditor training course.
• Awareness Training on HACCP (Hazard Analysis Critical Control Point).
• Successfully completed microbiological training.
• Training on DuPont Safety.
• FDA approved Competent Technical Staff (CTS) for Small Volume Parental, Tablet, capsule, Analytical & Micro biological. Authorized by Drugs Control Office Govt. of Assam, Guwahati