KALAISELVAN's Profile
KALAISELVAN | |
Head/VP/GM-Production/Manufacturing, Orchid Chem & Pharma | |
 | Orchid Chem & Pharma  |
Professional summary
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Current Experience:
Head/VP/GM-Production/Manufacturing, Orchid Chem & Pharma
Previous: Sr.Manager, Now TTK LIG Ltd
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GANDHIGRAM UNIVERSITY
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15.5 Years
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Pharma API-Management
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Contribution score:(62 points)
- Contacts: 3 connections, 2 following, 2 followers
KALAISELVAN's Experience
| Current : |
Head/VP/GM-Production/Manufacturing, Orchid Chem & Pharma |
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| Pharmaceuticals | ||
| Previous : |
Sr.Manager, Now TTK LIG Ltd |
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| Chennai | ||
Worked from 1994 to 1996 | ||
Brief summary :
Initially started the career at LRC Virudhu nagar [Now TTK LIG Ltd] as a Quality assurance supervisor trainee in June 1994 for about four months then changed in to API manufacturing line. Orchid Chemicals and Pharmaceuticals Ltd., Chennai since September end 1994 - Joined as Production Chemist and rose to the post of Sr.Manager - Manufacturing Non sterile.[With on line compliance in quality] Career path: 1994-1996-Chemist 1996-1999-Sr.chemist [Shift In charge] 1999-2001-Executive [Sr.Shift-In charge taking plant in charge role in deputation] 2001-2004-Sr.Executive [Single plant manager] 2004-2006-Asst.Manager [Two plant manager 2006-2008-Deputy Manager [Three plants Manager] 2008-2010 Manager-Non sterile production. [Multi plants manger-Position reports Sr.GM-Manufacturing] 20010-2011 June-Sr.Manager-manufacturing 2011 July onwards working as a AGM -Manufacturing at Matrix labs [A Mylan company MNC] in a fully regulated market API manufacturing block with full Gmp compliance.[Hyderabad].Here I got a opportunity to face SAP-GO LIVE experience and successful implementation of the same.Then I got the opportunity for the preparation of WHO audit and successful completion of the same on 25.08.11. Key Deliverables: Steering new application development initiatives; analysing existing processes and redesigning them for enhancing operational efficiency. Having good exposure on QMS and faced lot of regulatory audits like US-FDA,EDQM,MHRA,DANISH ,PMDA-Japan and TGA. Production planning as per the market requirement from raw material to various intermediate. Ensuring proper planning and maintaining the inventory minimum. Managing three production blocks [Two API Block and one intermediate] having 75 employees and position reports to Sr.GM-Production. Investigating the OOS in such a way not to reoccur the same again. Analysing each individual equipment process, validation and capabilities, suggesting balance equipments to further increase production. Conceptualising and implementing innovative cost reduction and value engineering strategies. Monitoring complete in-process quality control and continuous improvement in process capabilities. Investigating any Yield deviation/ Quality related issues in the Process. Monitoring and minimizing the Solvent loss and increasing recovered solvent usage in the process. Generating innovative ideas to improve the quality and quantity of the drug intermediate and API. Preparing SOP for Plant Operations and Cleaning Procedure in Multi-purpose Production Facility. Conducting Self Inspection / Internal Quality Audits and Training Class on SOPs and critical operation of process. Monitoring GMP compliance in Manufacturing Facility as per ICH Q7. As a internal trainer in the organisation for cGMP and safety contributed for training more people. Preparing Batch processing Record (BPR), Monthly Report, Campaign Report of intermediate API, Key Performance Indicator Report, etc. Developing and analysing cleaning validation /product change. Conducting process hazardous analysis for all the process, safety observation audit, incident investigation using Why tree analysis. Delegating work schedules; leading and monitoring performance of team to ensure efficiency in operations. Participating with project for any facility modification to make the system for new process. Taking process demo from R and D level and convert in to commercial scale up. Monitoring the solvent loss and maintaining the solvent coefficient. Initiating QA related document like planned deviation, facility change control, APR, non confirming material disposal report etc as per requirement. Highlights: Effectively managed production facility contributing around 15% of net turnover of the organization; the facility is approved by EDQM and USFDA. Functioned as Production In charge - Production in M/S Orchid Chemicals and Pharmaceutical Ltd., one of the worlds largest producer of Cephlosphorins based drugs manufacture (world 5th largest producer in this range of product) and 100 % Export Oriented Unit. Productivity enhancement initiative undertaken: Almost in all products yield improved by 20.0% by fine tuning the process and batch cycle time was reduced by better utilization of equipment. Streamlined Ceftiofur Hydrochloride Process - 100% failure converted into 0% failure by improving the quality of FURACA and Cefotaxime Process changed the washing pattern which results in quality improvement. Cefepime Process Impurity Formation was reduced which results in yield improvement with out the change in quality. Appropriate CAPA identified and implemented in the IEIPC intermediate for preventing reaction failure and degradation as it is a les stable intermediate. Conducting pre campaign meeting discussing the previous campaign learning to all the operating personnel for assuring the budgeted yield and quality. Doing PHA study with CFT for assuring the process safety in place before starting the production. During fire incident in orchid; participated in the fire extinguishing; appreciated and awarded by M.D. Maintained and achieved production as per the production planning and controlling the inventory. Went to china [Orchid JV Company] as a technology transfer key member for the product scale up [Cefonicid sodium sterile] and completed successfully. Cefazoiln sodium USFDA inspection faced and got approval. Professionally trained as a safety expert by DUPONT on various concepts like SOA, PHA [hazop, fmea, rcm etc], INCIDENT INVESTIGATION BY WHY TREE method, PSSR, PSI, and PSRM and Mechanical Integrity to adopt and train safety culture in the Organisation. Maintaining Purified water plant as per the requirement. Having exposure on all utility operations. Having exposure on solvent recovery. Having exposure on EMS. To import safety culture and assuring safety in the organisation we trained all the operation people to take line responsibility. Preparation of PSI package in the shop floor to have better control on PSRM. Preparation of process / cleaning validation protocol, excecuting and preparation of report. Preparation of APR.Performing HVAC validation. Worked in API plants from project stage onwards erection and commissioning. API-Block produced particle free Cefixime E as well as CPP to meet the Japanese market. Having the exposure as a CFT member to all stages of Ceftibutene API from ZEATA stage to till the final API. Similarly Cefcapapene Pivoxil from 7-ACA onwards. Cefditorin Pivoxil filing batches taken with all precautions with the help of PDL. Taken appropriate CAPA to resolve filtration problem of Cefazolin sodium sterile in the non sterile stage itself. From Chemist onwards worked in various phases with various bosses [Experts] to learn more about the technical skills, planning, leadership and cost effectiveness. Being a chemist worked closely with PDL and RD for successful implementation of process improvement and new projects. Latest with IE concept manufacturing efficiency improvement done in APIs like Cefxime-E, CPP and CRC.The gross margin due to this is 15.0crores in this financial year. Products Handled: Cefotaxime Acid Ceftriaxone Sodium Ceftazidime pentahydrate Cefepime Hydrochloride Cefpirome Sulphate Cephalothin Acid Cefdinir [Form A and B] Cefixime Ceftiofur Hydrochloride Ceftiofur Sodium [NIP] Cefopodoxime proxetil Ceftibutene Cefcapene pivoxil Cefoperazone acid Cefditorin pivoxil Ceforanide Cefonicid etc Ceftezole Cefazolinsodium Cefazolin acid pure Lot of intermediates of the all listed products. Cefuroxime axetil Cefuroxime acid Emtricitabine Levofloxacine Sertraline hydrochloride [Form I and II] # Now at matrix labs high responsibility with online Qulaity compliance for the manufacturing block which is manufacturing Emtricitabine WHO and PEFAR, levoflaxacine and Sertraline HCl and its relevant intermediates etc. | ||
KALAISELVAN's Education
GANDHIGRAM UNIVERSITY |
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| M.Sc | |
| India | |
| From 1992 to 1994 | |
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Brief summary :
Gold medalist in MSC Applied chemistry | |
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KALAISELVAN's communities
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11218 members, 39 jobs, 258 articles, 148 questions, 382 debates, 166 idea contests.
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