SALES, MARKETING AND BUSINESS DEVELOPMENT OF HIGH TECH CAPITAL GOODS IN PHARMACEUTICALS AND COSMETIC INDUSTRY.WORKING IN HAND TO HAND WITH THE CUSTOMER AND THE TECHNICAL TEAM IN DEFINING CONCEPTUALISING THE TECHNICAL SPECIFICATIONSTECHNICAL SALES AND MARKETING OF THE HIGH TECH STERILE FILLING AND SEALING LINES, PACKAGING LINES.NEGOTIATIONSPROJECT MANAGEMENT TILL FAT AND SAT

DEVELOPMENT OF STABLE PACKAGING DEVICE. APPLIED FOR TWO DEVICE PATENTS. REGULATORY AFFAIRSQUALITY ASSURANCEVENDOR DEVELOPMENTDEVELOPING POTENTIAL DISTRIBUTORS ACROSS GLOBE

BUSINESS DEVELOPMENT AND TECHNICAL SERIVICES FOR STATE OF ART MACHINERY FROM MARCHESINI GROUP ITALY, BREVETTI ANGELA SRL ITALY, LAST TECHNOLOGIES ITALY, CMP PHARMA (VISUAL INSPECTION INTIGRITY TESTING MACHINE), GDN WATER SYSTEM ITALY, PRINTING INTERNATIONAL BELGIUM, SEAVISION ITALY.

QUALITY ASSURANCE, BUSINESS DEVELOPMENT, GLOBAL AUDIT AND COMPLIANCE, VENDOR DEVELOPMENT CONTRACT MANUFACTURING SITES ACROSS GLOBE AND KEY API MANUFACTURERS ACROSS THE GLOBE

MANAGING BETA LACTUM DRY POWDER INJECTABLE LINE. PRODUCTION PLANNING SCHEDULING AND EXECUTION. PLANNING PERIODIC VALIDATION OF AUTOCLAVES, DEPYROGENATION TUNNEL, VIAL WASHING MACHINE, BUNG PROCESSOR, STERILE DRY POWDER FILLING AND SEALING MACHINE TILL PACKAGING AS PER THE INTERNATIONAL ACCEPTABLE GUIDELINES. FACING THE REGULATORY AUDITSMAINTAINING DOCUMENTATION AS PER cGMP AND OTHER REGULATORY REQUIREMENT. IMPLEMENTATION OF SOPs, IMPLEMENTATION OF QUALIFICATION AS PER THE GLOBAL REGULATORY REQUIREMENT. REVIEWING USER REQUIREMENT SPECIFICATION FOR NEW EQUIPMENTS.CHANGE CONTROLS, DEVIATION CONTROL, CAPA, TRAINING OF PERSONNEL IN cGMP & ASEPTIC PRACTICES SOPs etc. PARTICLE COUNT TRENDING ASSISTING QA IN GLOBAL REGULATORY AUDITS AND COMPLIANCE

LEADING AND MANAGING THE STERILE EYE DROP MANUFACTURING. TRAINING THE TEAM. IMPLEMENTATION OF cGMP ON SHOP FLOOR ALL THE TIME. REVIEW THE BATCH MANUFACTURING AND PACKAGING RECORDS BEFORE BATCH RELEASE. WORKING IN TANDEM WITH QA TEAM TO ENSURE QUALITY ASSURANCE PRINCIPLES ARE IMPLEMENTED AND FOLLOWED ON SHOP FLOOR. ENSURING ALL TIME READINESS FOR GMP AUDITS. REPORTING AND HANDLING OF CHANGE CONTROLS, DEVIATIONS. IDENTIFYING ROOT CAUSE ANALYSIS. ASEPTIC PROCESS SIMULATION. PERIODIC TRAINING OF TEAM IN ASEPTIC PROCESSING. COMMUNICATING WITH CROSS FUNCTIONAL TEAM LIKE QUALITY CONTROL, QUALITY ASSURANCE, RAW AND PACKAGING MATERIAL STORES, HUMAN RESOURCES, HOUSE KEEPING, MIDDLE LEVEL MANAGEMENT, PRODUCTION PLANNING AND CONTROL. ENSURING THE PPM (PLANNED PREVENTIVE MAINTANANCE OF ASPETIC FILLING AND SEALING MACHINES, AUTOCLAVES, COMPOUNDING EQUIPMENTS, LAMINAR AIR FLOW, CONTINOUS VIABLE/NON VIABLE PARTICLE MONITORING TO ENSURE THERE IS MINIMAL INTERVENTION DURING ASEPTIC PROCESSING. PERIODIC VALIDATIONS TO ENSURE STATE OF CONTROL. PLANNING NEW PRODUCT LAUNCHES.ENSURING SMOOTH EXECUTION OF NDA AND ANDA PRODUCTS AND PILOT AND REGULATORY SUBMISSION BATCHES.

MANAGING CEPHALOSPORIN DRY POWDER INJECTABLE LINE. PRODUCTION PLANNING SCHEDULING AND EXECUTION. PLANNING PERIODIC VALIDATION OF AUTOCLAVES, DEPYROGENATION TUNNEL, VIAL WASHING MACHINE, BUNG PROCESSOR, STERILE DRY POWDER FILLING AND SEALING MACHINE TILL PACKAGING AS PER THE INTERNATIONAL ACCEPTABLE GUIDELINES. FACING THE REGULATORY AUDIT LIKE ANVISA, TGA AUSTRALIA UK MHRAENSURING ADHERENCE TO cGMP AS PER MAJOR REGULATORY GUIDELINES.ENSURING IMPLENTATION OF SOPs, QUALIFICATIONS, USER REQUIREMENT SPECIFICATION FOR NEW MACHINERIES AND EQUIPMENTICH Q9 AND ICH Q10ACTIVE PARTICIPATION IN REGULATORY AUDITS COMPLIANCE. TRAINED IN MINITAB AND OTHER STATISTICAL ANALYSIS OF DATA.TRAINED IN INVESTIGATION TOOLS LIKE ISHIKAWA, 6M AND 4P.TOYOTA 5 WHY?VENDOR AUDIT INTERNAL AUDITS

Ensuring smooth running of the department, handling NDA and ANDA execution batches. First Exports to USA from the plant. participated and faced the USFDA, UK MHRA, ANVISA regulatory audits. ensuring total automation of entire line till packaging intervention free. Periodic qualifications and validations of autoclaves, aspetic simulations, area qualifications.Risk Analysis (FMEA)SOP reviews.Handling Change controls, deviations, implemetation of CAPA. Closely working with R&D for the new launch planning and execution.Keeping the lines always ready for the regulatory audits. Closely working with export department for smooth execution of export orders(Its 100% Export oriented unit)

It was a part of MERCK KGaA Germany. One of the biggest plant in India manufacturing Sterile Injectables, soft gelatins capsules, bulk drug Vitamin-E and Guazelene. Worked in Sterile section manufacturing Polybion and Neurobion InjectionsFaced WHO GMP audit.Handling 3 compact lines, 2 of Bosch make with pyroklenz hot air tunnel & 1 machine with petals make. Manufacturing approximately around 15 millions ampoules per month. Handling Packaging department.Validation of sterile area viz. particle count, air velocity, air changes, dope test, smoke test media filling.Batch manufacturing, aseptic filteration and handling potassium cyanide during manufacturing process and disposal of empty containers after use.Challenging of Aseptic process simulation of liquid filling line by growth promoting media.Validation of autoclave viz. heat penetration , heat distribution, biological validation Fo values.Validation of fully automatic Eisai ampoule inspection machine.Validation of washing m/c viz. particle count ,dope test ,heat distribution , endotoxin challenge test of hot air tunnel.SAP

STERILE FACILITY MANUFACTURING GLASS AMPOULES, LIQUID ORALS, TABLETS AND CAPSULES

MANUFACTURING OF LIQUID ORAL FORMULATIONS, TABLETS, CAPSULES, DRY SYRUP. INSTALLATION AND QUALIFICATION OF FULLY AUTOMATIC LIQUID ORAL FILLING AND SEALING LINE WITH A CAPACITY OF 30000 BOTTLES PER SHIFT. INSTALLATION AND QUALIFICATION OF PURIFIED WATER SYSTEMPRODUCTION PLANNINGREVIEW OF BATCH MANUFACTURING RECORD AND BATCH PACKING RECORDSQUALIFIED PERSON IN LIQUID ORAL SECTIONSHIFT INCHARGE